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ENFORCEMENT RULE OF THE MEDICAL DEVICES ACT

Wholly Amended by Ordinance of the Prime Minister No. 1181, Jul. 29, 2015

Amended by Ordinance of the Prime Minister No. 1284, jun. 15, 2016

Ordinance of the Prime Minister No. 1307, Jul. 29, 2016

Ordinance of the Prime Minister No. 1354, Jan. 4, 2017

Ordinance of the Prime Minister No. 1389, May 1, 2017

Ordinance of the Prime Minister No. 1469, jun. 14, 2018

Ordinance of the Prime Minister No. 1512, Dec. 31, 2018

Ordinance of the Prime Minister No. 1542, jun. 12, 2019

Ordinance of the Prime Minister No. 1567, Oct. 22, 2019

Ordinance of the Prime Minister No. 1580, Dec. 23, 2019

 Article 1 (Purpose)
The purpose of this Rule is to prescribe the matters mandated by the Medical Devices Act and the Enforcement Decree of that Act and matters necessary for enforcing said Act and Decree.
 Article 2 (Standards for Classification and Designation of Classes)
The standards and procedures for the classification and designation of the class of each medical device under Article 3 (2) of the Medical Devices Act (hereinafter referred to as the "Act") shall be as specified in attached Table 1.
 Article 3 (Procedures for Application for Manufacturing Business Permission)
(1) A person who intends to obtain manufacturing business permission of medical devices under the main clause of Article 6 (1) of the Act shall submit an application in attached Form 1 (including an application in electronic form) to the head of a regional office of food and drug safety having jurisdiction over the location of a factory, along with the following documents (including electronic documents). In such cases, where there exist at least two factories in different locations, such person may submit the application to the head of a regional office of food and drug safety having jurisdiction over either of such locations:
1. A medical certificate for which six months have not elapsed since the issuance date and which is issued by a medical doctor evidencing that he or she does not fall under the main clause of Article 6 (1) 1 of the Act or by a medical specialist evidencing that he or she falls under the proviso of that subparagraph (a corporation shall not submit such medical certificate);
2. A medical certificate for which six months have not elapsed since the issuance date and which is issued by a medical doctor evidencing that he or she does not fall under Article 6 (1) 3 of the Act (a corporation shall not submit such medical certificate);
3. A document verifying the qualifications of a quality manager under Article 6 (7) of the Act.
(2) Upon receipt of an application under paragraph (1), the head of a regional office of food and drug safety shall verify a corporation registration certificate (limited to a corporation) through administrative data matching under Article 36 (1) of the Electronic Government Act.
(3) Where an application for permission under paragraph (1) meets the standards, the head of a regional office of food and drug safety shall issue a permit in attached Form 2 to the applicant and state the following matters in the manufacturing business permission register: <Amended by Ordinance of the Prime Minister No. 1567, Oct. 22, 2019>
1. The permission number and permission date;
2. The name and resident registration number of a manufacturer (in cases of a corporation, the name and resident registration number of its representative);
3. The name and location of a factory;
4. The name, resident registration number, and classification of qualifications of a quality manager.
 Article 4 (Medical Devices Subject to Manufacturing Permission, Manufacturing Certification, or Manufacturing Notification)
(1) Medical devices subject to manufacturing certification or manufacturing notification by item category under Article 6 (2) 1 of the Act shall be classified as follows:
1. Manufacturing certification by item category: Medical devices determined and publicly notified by the Minister of Food and Drug Safety, among Class II medical devices, the class of which is designated pursuant to Article 2 (hereinafter referred to as "class");
2. Manufacturing notification by item category: Medical devices determined and publicly notified by the Minister of Food and Drug Safety, among Class I medical devices.
(2) Medical devices subject to manufacturing permission, manufacturing certification, or manufacturing notification by item under Article 6 (2) 2 of the Act shall be classified as follows:
1. Manufacturing permission by item: The following medical devices:
(a) Class III and Class IV medical devices;
(b) Medical devices excluding those under paragraph (1) 1, item (c) of this subparagraph, and subparagraph 2 of this paragraph, among Class II medical devices;
(c) Medical devices that are essentially different from those already permitted, certified, or notified in terms of structures, principles, performance, intended uses, methods for use, etc., among Class I and Class II medical devices;
2. Manufacturing certification by item: Medical devices determined and publicly notified by the Minister of Food and Drug Safety excluding those under paragraph (1) 1, among Class II medical devices;
3. Manufacturing notification by item: Medical devices excluding those under paragraph (1) 2 and subparagraph 1 (c) of this paragraph, among Class I medical devices.
 Article 5 (Procedures for Manufacturing Permission)
(1) A person who intends to obtain manufacturing permission of medical devices under Article 6 (2) of the Act shall submit an application in attached Form 3 (including an application in electronic form) to the Minister of Food and Drug Safety, along with the following documents (including electronic documents):
1. Documents evidencing that he or she secures facilities and manufacturing and quality management systems under Article 6 (4) of the Act;
2. Technical documents, clinical trial data, etc. (hereinafter referred to as "technical documents, etc.") or a notice of the results of reviewing technical documents, etc. under Article 9 (4) for which two years have not elapsed since the issuance date: Provided, That in cases falling under the proviso of Article 9 (1), a notice of the results of reviewing technical documents, etc. shall be submitted;
3. A copy of a contract for entrusting the manufacturing processes or testing for quality management, where such contract is concluded.
(2) Where a product of which an application for manufacturing permission is filed under paragraph (1) is deemed to meet the standards, the Minister of Food and Drug Safety shall issue the applicant with a manufacturing permit in attached Form 4 and enter the following matters in the manufacturing permission register:
1. The permission number and permission date;
2. The names (the product name, item name, and model name).
(3) The Minister of Food and Drug Safety shall determine and publicly notify the guidelines for preparing attached documents necessary to apply for manufacturing business permission of medical devices under Article 3 (including conditional manufacturing business permission and permission for modification thereof) and those necessary to apply for manufacturing permission under paragraph (1) (including conditional manufacturing permission and permission for modification thereof), requirements for each document, the scope of exemption, and other details.
(4) Where the Minister of Food and Drug Safety receives an application for new health technology assessment under Article 3-2 (2) of the New Health Technology Assessment Rules, an application, etc. for verifying health care benefit items and non-benefit items under Article 9-2 (2) of the Rules on Standards for Health Care Benefits Covered by National Health Insurance, or a written objection under Article 9-2 (4) of the Rules on Standards for Health Care Benefits Covered by National Health Insurance while receiving an application for manufacturing permission filed under paragraph (1), he or she shall, without delay, forward the relevant application, etc. to the Minister of Health and Welfare and the President of the Health Insurance Review and Assessment Service. In such cases, the Minister of Food and Drug Safety may mutually share data related to the relevant application for manufacturing permission with the Minister of Health and Welfare or the President of the Health Insurance Review and Assessment Service; present his or her opinions on new health technology assessment, medical care benefit items, and non-benefit items; and refer to the data forwarded under paragraph (5) when granting manufacturing permission. <Newly Inserted by Ordinance of the Prime Minister No. 1307, Jul. 29, 2016>
(5) Where the Minister of Food and Drug Safety is forwarded the results of new health technology assessment, the results of verifying health care benefit items and non-benefit items, etc. by the Minister of Health and Welfare and the President of the Health Insurance Review and Assessment Service pursuant to Article 4 (2) of the New Health Technology Assessment Rules or the main clause of Article 9-2 (3) and paragraph (4) of that Article of the Rules on Standards for Health Care Benefits Covered by National Health Insurance, he or she shall immediately notify the relevant applicant of such results, etc. <Newly Inserted by Ordinance of the Prime Minister No. 1307, Jul. 29, 2016>
(6) The matters prescribed in paragraphs (4) and (5) shall also apply to conditional manufacturing permission granted under Article 7 (1) of the Act or permission for modification granted under Article 12 (1) of the Act. <Newly Inserted by Ordinance of the Prime Minister No. 1307, Jul. 29, 2016>
(7) Except as provided in paragraphs (4) through (6), details necessary for provision, etc. of data and opinions among institutions shall be determined and publicly notified by the Minister of Food and Drug Safety. <Newly Inserted by Ordinance of the Prime Minister No. 1307, Jul. 29, 2016>
 Article 6 (Procedures for Manufacturing Certification)
(1) A person who intends to obtain manufacturing certification of medical devices under Article 6 (2) of the Act shall submit an application in attached Form 5 (including an application in electronic form) to the head of the National Institute of Medical Device Safety Information established under Article 42 of the Act (hereinafter referred to as the "Information Institute") entrusted with the affairs concerning certification under Article 44 (2) of the Act, along with the documents referred to in the subparagraphs of Article 5 (1) (including electronic documents). <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(2) Where medical devices of which an application for manufacturing certification is filed under paragraph (1) are deemed to meet the standards, the head of the Information Institute shall issue a manufacturing certificate in attached Form 6 to the applicant, and shall enter the following matters in the manufacturing certification register: <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
1. The certification number and certification date;
2. The names (the product name, item name, and model name).
(3) The Minister of Food and Drug Safety shall determine and publicly notify the guidelines for preparing attached documents necessary to apply for manufacturing certification under paragraph (1) (including conditional manufacturing certification and certification of modification thereof), requirements for each document, the scope of exemption, and other details.
 Article 7 (Procedures for Manufacturing Notification)
(1) A person who intends to file a manufacturing notification of medical devices under Article 6 (2) of the Act shall submit a notification in attached Form 7 (including a notification in electronic form) to the head of the Information Institute entrusted with the affairs concerning notification under Article 44 (2) of the Act, along with the documents referred to in Article 5 (1) 3. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(2) Where a notification is filed under paragraph (1), the head of the Information Institute shall enter the following matters in the manufacturing notification register: <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
1. The notification number and notification date;
2. The names (the product name, item name, and model name).
(3) The Minister of Food and Drug Safety shall determine and publicly notify the guidelines for preparing attached documents necessary to file a manufacturing notification under paragraph (1) (including a conditional manufacturing notification and notification of modification thereof), requirements for each document, the scope of exemption, and other details.
 Article 8 (Standards for Facilities and Manufacturing and Quality Management Systems)
(1) Standards for facilities and manufacturing and quality management systems to be secured by a person who intends to obtain manufacturing business permission or who intends to obtain manufacturing permission or manufacturing certification or to file a manufacturing notification under the main clause of Article 6 (4) of the Act shall be as specified in attached Table 2.
(2) "Cases prescribed by Ordinance of the Prime Minister, such as entrusting testing for quality management or manufacturing processes" in the proviso of Article 6 (4) of the Act means where a person who intends to obtain manufacturing business permission or who intends to obtain manufacturing permission or manufacturing certification or to file a manufacturing notification entrusts manufacturing processes or entrusts testing for quality management to a medical device testing and inspection institution under Article 6 (2) 4 of the Act on Testing and Inspection in the Food and Drug Industry (hereinafter referred to as "medical device testing and inspection institution"), an institution conducting non-clinical studies under Article 10-2 (1) of the Act (hereinafter referred to as "institution conducting non-clinical studies"), or a manufacturer whose compliance is recognized under subparagraph 2 (f) of attached Table 2. In such cases, the person who intends to obtain manufacturing business permission or who intends to obtain manufacturing permission or manufacturing certification or to file a manufacturing notification need not secure the facilities of a factory specified in subparagraph 1 (a) of attached Table 2 according to the following classifications: <Amended by Ordinance of the Prime Minister No. 1389, May 1, 2017>
1. Where manufacturing processes are entrusted: Manufacturing facilities and instruments related to the entrusted processes;
2. Where testing for quality management is entrusted to a medical device testing and inspection institution, an institution conducting non-clinical studies, or a manufacturer whose compliance is recognized under subparagraph 2 (f) of attached Table 2: Laboratories for quality management, and facilities and instruments related to testing.
 Article 9 (Review of Technical Documents)
(1) A person who intends to obtain manufacturing permission or manufacturing certification may have the technical documents, etc. to be submitted under Article 6 (5) of the Act pre-reviewed by the Minister of Food and Drug Safety with regard to their compliance: Provided, That in cases of medical devices that are essentially equivalent to those already permitted, certified, or notified in terms of structures, principles, performance, intended uses, methods for use, etc. and fall under the items determined by the Minister of Food and Drug and Safety, the technical documents, etc. shall be reviewed by an institution reviewing technical documents under Article 6-4 (1) of the Act (hereinafter referred to as "institution reviewing technical documents"). <Amended by Ordinance of the Prime Minister No. 1389, May 1, 2017>
(2) A person who intends to have technical documents, etc. reviewed under paragraph (1) shall submit a written request for review in attached Form 8 (including a written request for review in electronic form) to the Minister of Food and Drug Safety or the head of an institution reviewing technical documents, along with the following data (including data in electronic form): Provided, That in cases of medical devices that are essentially equivalent to those already permitted in terms of structures, principles, performance, intended uses, methods for use, etc., other than medical devices determined and publicly notified by the Minister of Food and Drug Safety for which submission of data regarding clinical trials is deemed necessary, the data referred to in subparagraphs 5 through 7 need not be submitted: <Amended by Ordinance of the Prime Minister No. 1542, Jun. 12, 2019>
1. Data regarding comparison with products already permitted;
2. Data regarding intended uses;
3. Data regarding operating principles;
4. The following data regarding test specifications, grounds for establishing such specifications, and actual measured values to verify the performance and safety of products: Provided, That where neither domestic nor international test specifications exist, data regarding test specifications established by the person who intends to have technical documents, etc. reviewed to verify the performance and safety of products, grounds for establishing such specifications, and actual measured values:
(a) Data regarding electrical and mechanical safety;
(b) Data regarding biological safety;
(c) Data regarding radiation safety;
(d) Data regarding safety of electromagnetic waves;
(e) Data regarding performance;
(f) Data regarding physical and chemical properties;
(g) Data regarding stability;
5. Data regarding origins, discovery, and reasons for development;
6. Data regarding clinical trials;
7. Data regarding the current status, etc. of use in foreign countries.
(3) Notwithstanding paragraph (2), a person who intends to have technical documents, etc. reviewed with regard to in vitro diagnostic medical devices shall submit a written request for review in attached Form 8 (including a written request for review in electronic form) to the Minister of Food and Drug Safety or the head of an institution reviewing technical documents, along with the following data (including data in electronic form): <Amended by Ordinance of the Prime Minister No. 1354, Jan. 4, 2017 >
1. Data regarding reasons for development, measurement principles and methods, and the current status of domestic and international use;
2. Data regarding raw materials and manufacturing methods;
3. Data regarding intended uses;
4. Data regarding storage methods and the period of use or the expiration date;
5. The following data to verify the performance of the products:
(a) Data regarding analytic performance studies;
(b) Data regarding clinical performance studies;
(c) Data regarding quality management testing;
(d) Data regarding reference materials, specimen storage, etc.;
6. Data regarding the safety of handlers of in vitro diagnostic medical devices;
7. Data regarding comparison with products already permitted.
(4) Upon receipt of a request for review under paragraph (2) or (3), the Minister of Drug and Food Safety or the head of an institution reviewing technical documents shall review the relevant technical documents, etc. and notify the applicant of the results as prepared in attached Form 9.
(5) The Minister of Food and Drug Safety shall determine and publicly notify the guidelines for preparing attached documents necessary to review technical documents, etc.; requirements for each attached document and procedures for and scope of exemption thereof; scope of and standards and procedures for review; management standards for clinical performance studies; and other details. <Amended by Ordinance of the Prime Minister No. 1354, Jan. 4, 2017>
 Article 10 (Exemption from Manufacturing Business Permission of Medical Devices)
The following medical devices may be manufactured without manufacturing business permission under Article 6 (1) of the Act or without manufacturing permission, manufacturing certification, or manufacturing notification under paragraph (2) of that Article: <Amended by Ordinance of the Prime Minister No. 1284, Jun. 15, 2016; Ordinance of the Prime Minister No. 1469, Jun. 14, 2018; Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
1. A medical device subject to clinical trials, for which approval of a clinical trial protocol is granted under the main clause of Article 10 (1) of the Act;
2. A separate medical device necessary for clinical trials, for which approval of a clinical trial protocol need not be granted under the proviso of Article 10 (1) of the Act;
3. A separate medical device necessary for clinical trials regarding drugs, etc., for which approval of a clinical trial protocol shall be granted under Article 34 of the Pharmaceutical Affairs Act;
4. A medical device manufactured to obtain manufacturing permission or manufacturing certification of medical devices or to file a manufacturing notification of medical devices;
5. A medical device used for the purpose of research, such as product development;
6. A medical device determined and publicly notified by the Minister of Food and Drug Safety, such as a medical device for self-use and relief operations;
7. Deleted; <by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
8. A medical device determined and publicly notified by the Minister of Food and Drug Safety, which is used in clinical laboratories deemed suitable by him or her based on the evaluations of quality management systems, inspection performance, competence, etc. (referring to places where the diagnosis, inspection, etc. of diseases are conducted; hereinafter the same shall apply).
 Article 11 (Qualifications for Quality Managers)
(1) A person who intends to obtain manufacturing business permission under Article 6 (1) of the Act shall assign at least one quality manager to each factory.
(2) The affairs of a quality manager may be performed by a person with any of the following qualifications: <Amended by Ordinance of the Prime Minister No. 1284, Jun. 15, 2016>
1. A person with the license classified as follows under the Medical Service Technologists, etc. Act:
(a) Where eyeglass lenses or contact lenses are manufactured or imported: Opticians;
(b) Where materials used in dental clinics are manufactured or imported: Dental technicians or dental hygienists;
(c) Where radiation-generating devices are manufactured or imported: Radiological technologists;
(d) Where in vitro diagnostic medical devices are manufactured or imported: Medical technologists;
(e) Where medical devices necessary for physical therapy or rehabilitation training are manufactured or imported: Physical therapists;
2. A person with qualifications as a biomedical engineer or quality management engineer under the National Technical Qualifications Act;
3. A person who has earned a bachelor's degree (including a person deemed to have educational attainment equal to or higher than such degree under statutes or regulations; hereafter in this Article, the same shall apply) from a school under the subparagraphs of Article 2 of the Higher Education Act (excluding a junior college under subparagraph 4 of that Article; hereafter in this Article referred to as "university, college, etc.") and who has majored in the field of natural science, engineering, or medicine under Article 2 (9) of the Regulations on the Establishment and Operation of Universities and Colleges (hereafter in this Article referred to as "field related to medical devices");
4. A person who has earned a bachelor's degree from a university, college, etc. in a field not related to medical devices and who has earned a master's degree or higher from a graduate school under Article 29 of the Higher Education Act in a field related to medical devices;
5. A person who has earned a bachelor's degree from a university, college, etc. in a field not related to medical devices and has engaged in quality management for at least one year in a company that manufactures or imports medical devices;
6. A graduate of a junior college under subparagraph 4 of Article 2 of the Higher Education Act (including a person deemed to have educational attainment equal to or higher than such college under statutes or regulations; hereafter in this Article, the same shall apply) who has majored in a field related to medical devices and has engaged in quality management for at least one year in a company that manufactures or imports medical devices;
7. A graduate of a junior college under subparagraph 4 of Article 2 of the Higher Education Act who has majored in a field not related to medical devices and has engaged in quality management for at least three years (two years, in cases of a graduate of a junior college whose term of school years is three years under Article 48 (1) of the Higher Education Act) in a company that manufactures or imports medical devices;
8. A graduate of a high school or high technical school under subparagraph 3 of Article 2 of the Elementary and Secondary Education Act (including a person deemed to have educational attainment equal to or higher than such school under statutes or regulations, but excluding a person falling under subparagraph 9) who has engaged in quality management for at least five years in a company that manufactures or imports medical devices;
9. A graduate of a high school tailored to industry demand in a field related to medical devices under Article 90 (1) 10 of the Enforcement Decree of the Elementary and Secondary Education Act who has engaged in quality management for at least three years in a company that manufactures or imports medical devices;
10. A person who has engaged in quality management for at least six years in a company that manufactures or imports medical devices.
(3) Where a manufacturer has at least two quality managers under paragraph (1), the work shall be divided and the limits of the responsibilities of each quality manager shall be specified.
 Article 12 (Scope of Duties of Quality Managers)
(1) The scope of duties to be performed by quality managers under Article 6-2 (1) of the Act shall be as follows:
1. Inspecting the hygiene of employees thoroughly and providing them with education and training necessary to produce and import medical devices with excellent quality;
2. Supervising whether employees receive education and training under subparagraph 1;
3. Preparing standard work guidelines to manufacture medical devices in accordance with the standards for manufacturing and quality management systems specified in subparagraph 2 of attached Table 2 and requiring employees to manufacture medical devices in accordance with such guidelines;
4. Thoroughly conducting testing, inspections, or examinations necessary for the processes from the warehousing of raw materials to the release of finished products; preparing and keeping manufacturing management records and quality management records for each manufacturing unit; and retaining such records for five years from manufacturing dates (referring to a period corresponding to the life cycle of a product, where such life cycle exceeds five years);
5. Evaluating the results of quality management of factories and determining whether products are shipped;
6. Affairs related to the establishment, implementation, and maintenance of quality management systems in accordance with the standards for manufacturing and quality management systems specified in subparagraph 2 of attached Table 2;
7. Managing the facilities of factories in a sanitary manner so as not to cause any harm to health and hygiene and preventing cross-contamination, contamination from the outside, etc.;
8. Managing and supervising objects likely to cause any harm so that they are not placed in working places and preventing substances hazardous to public health from being generated in the working place;
9. Other affairs determined and publicly notified by the Minister of Food and Drug Safety, which are related to manufacturing management, quality management, and safety management, among the matters to be observed by manufacturers under Article 27 (1).
(2) Where a quality manager ceases to engage in quality management in the relevant workplace, he or she may submit a notification on non-working as a quality manager in attached Form 10 (including a notification in electronic form) to the head of the competent regional office of food and drug safety.
(3) No quality manger shall concurrently engage in affairs other than those referred to in paragraph (1): Provided, That the same shall not apply in any of the following cases:
1. Where he or she performs affairs not affecting the duties of a quality manager;
2. Where a manufacturer concurrently engages in import business, and a quality manager of the manufacturing company performs the affairs of a quality manager of the import company.
 Article 13 (Content and Hours of Education for Quality Managers)
(1) The content of education under Article 6-2 (2) of the Act shall be as follows:
1. The latest standard specifications for medical devices;
2. Statutes, regulations, systems, and technology necessary for safety management, such as ensuring the safety and effectiveness of medical devices;
3. Statutes, regulations, systems, and technology necessary for the manufacturing and quality management of medical devices;
4. Other matters determined by the Minister of Food and Drug Safety for the manufacturing management, quality management, and safety management of medical devices.
(2) Education shall be provided for at least eight hours per year.
(3) A quality manager shall receive education conducted by an institution offering education for quality managers under Article 14 (1) within three months from the date of commencement of work: Provided, That the same shall not apply where he or she completes education to be provided in the pertinent year before working as a quality manager.
 Article 14 (Designation of Institutions Offering Education for Quality Managers)
(1) The Minister of Food and Drug Safety may designate any of the following institutions or organizations as an institution offering education for quality managers (hereinafter referred to as "institution offering education") under Article 6-2 (4) of the Act: <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
1. The Information Institute;
2. Medical device-related institutions or organizations publicly announced by the Minister of Food and Drug Safety.
(2) A person who intends to apply for designation under paragraph (1) shall submit an application for designation as an institution offering education for quality managers of medical devices in attached Form 11 (including an application in electronic form) to the Minister of Food and Drug Safety, along with the following documents and data (including electronic documents):
1. Data regarding the current status of the operational organization and personnel to provide education;
2. Data regarding the current status of securing education facilities and equipment;
3. Evidentiary data regarding the calculation of tuition fees;
4. Regulations on implementation of education;
5. Basic education plans.
(3) Upon receipt of an application under paragraph (2), the Minister of Food and Drug Safety may conduct a fact-finding survey to evaluate whether the details of such application satisfy the requirements for designation determined and publicly notified by the Minister of Food and Drug Safety, such as facilities, equipment, and personnel for education.
(4) Where the Minister of Food and Drug Safety designates an institution offering education, he or she shall issue the applicant with a certificate of designation in attached Form 12. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(5) Where an institution offering education intends to modify its designated name, location, or representative under paragraph (4), it shall submit to the Minister of Food and Drug Safety an application for modification of designation as an institution offering education for quality managers of medical devices in attached Form 11-2 (including an application in electronic form) within 30 days from the date reasons for such modification occur, along with a certificate of designation as an institution offering education for quality managers of medical devices and documents verifying modified matters (including electronic documents). <Newly Inserted by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(6) The Minister of Food and Drug Safety may modify designation of an institution offering education after verifying an application, etc. prescribed in paragraph (5). In such cases, he or she shall issue a certificate of designation as an institution offering education for quality managers of medical devices, stating the modified matters therein. <Newly Inserted by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(7) Where the Minister of Food and Drug Safety designates an institution offering education under paragraph (4) or modifies designation under paragraph (6), he or she shall publicly announce the fact that such institution is designated or designation is modified, and the name and location of the institution, and the name of its representative on the website, etc. of the Ministry of Food and Drug Safety. <Newly Inserted by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(8) An institution offering education may receive tuition fees from educatees in consideration of the expenses incurred in education, such as expenses for educational materials and on-site training, and stipends for instructors. In such cases, the head of the institution offering education shall determine tuition fees not exceeding actual expenses. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(9) Except as provided in paragraphs (1) through (8), matters necessary for the designation, management, etc. of institutions offering education shall be determined and publicly notified by the Minister of Food and Drug Safety. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
 Article 15 (Methods and Procedures for Educating Quality Managers)
(1) An institution offering education designated by the Minister of Food and Drug Safety under Article 14 (4) shall develop educational materials and provide them to educatees.
(2) An institution offering education shall formulate an annual education plan including educatees and education content for the following year in accordance with the basic education plan under Article 14 (2) 5, and shall submit it to the Minister of Food and Drug Safety before the following business year commences.
(3) An institution offering education shall issue a certificate to a person who completes education, and shall record matters regarding provision of education such as a list of persons completing education and retain such records for two years from the date such matters are recorded.
(4) An institution offering education shall report records regarding the provision of education for the preceding year to the Minister of Food and Drug Safety by January 31 of the following year.
 Article 15-2 (Designation of Institutions Reviewing Technical Documents)
(1) A person who intends to be designated as an institution reviewing technical documents under Article 6-4 (1) of the Act shall meet the standards for designation determined and publicly notified by the Minister of Food and Drug Safety, such as organization and personnel necessary to review technical documents, etc. for each field, and operational standards.
(2) A person who intends to be designated as an institution reviewing technical documents shall submit to the Minister of Food and Drug Safety an application for designation as an institution reviewing technical documents on medical devices in attached Form 12-2 (including an application in electronic form), along with the following documents (including electronic documents):
1. Documents regarding the current status of organization and personnel (for the current status of personnel, including documents evidencing qualifications and work experience);
2. Documents regarding operational standards;
3. Documents regarding fields for reviewing technical documents, etc.;
4. Documents determined and publicly notified by the Minister of Food and Drug Safety, which prove financial capabilities to review technical documents, etc.
(3) Upon receipt of an application under paragraph (2), the Minister of Food and Drug Safety may conduct a fact-finding survey to evaluate whether the details of such application meet the standards for designation.
(4) Where the Minister of Food and Drug Safety designates an institution reviewing technical documents, he or she shall issue the applicant with a certificate of designation as an institution reviewing technical documents on medical devices in attached Form 12-3.
(5) Where an institution reviewing technical documents intends to modify any of the following matters, it shall submit to the Minister of Food and Drug Safety an application for modification of designated matters of an institution reviewing technical documents on medical devices in attached Form 12-4 (including an application in electronic form) within 30 days from the date reasons for such modification occur, along with a certificate of designation as an institution reviewing technical documents on medical devices and documents verifying modified matters (including electronic documents):
1. The representative of the institution reviewing technical documents;
2. The name and location of the institution reviewing technical documents;
3. Fields for reviewing technical documents, etc.
(6) Where the Minister of Food and Drug Safety modifies designation of an institution reviewing technical documents, he or she shall issue a certificate of designation as an institution reviewing technical documents on medical devices, stating the modified matters therein.
(7) Where the Minister of Food and Drug Safety designates an institution reviewing technical documents or modifies designation thereof, he or she shall publicly announce the name, location, representative, etc. of the institution on the website, etc. of the Ministry of Food and Drug Safety.
(8) Details regarding the scope of the documents to be submitted under paragraph (2) shall be determined and publicly notified by the Minister of Food and Drug Safety.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1389, May 1, 2017]
 Article 15-3 (Matters to Be Observed by Institutions Reviewing Technical Documents)
"Matters prescribed by Ordinance of the Prime Minister" in Article 6-4 (3) of the Act means the following:
1. The operational standards of institutions reviewing technical documents shall be observed, as determined and publicly notified by the Minister of Food and Drug Safety;
2. The results of reviewing technical documents shall be reported to the Minister of Food and Drug Safety, as determined and publicly notified by the Minister of Food and Drug Safety;
3. A copy of a notice of the results of reviewing technical documents and records regarding the review of such documents shall be retained for five years from the date the results of reviewing the documents are notified;
4. Other matters determined and publicly notified by the Minister of Food and Drug Safety regarding the preparation, issuance, etc. of a notice of the results of reviewing technical documents shall be observed.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1389, May 1, 2017]
 Article 16 (Application for Conditional Permission)
(1) A person who intends to obtain conditional manufacturing business permission under Article 7 (1) of the Act shall submit an application in attached Form 1 (including an application in electronic form) to the head of a regional office of food and drug safety having jurisdiction over the location of a factory, along with the following documents (including electronic documents). In such cases, the head of the regional office of food and drug safety shall verify a corporation registration certificate (limited to a corporation), a certified copy of the land register, and a certified copy of the building register through administrative data matching under Article 36 (1) of the Electronic Government Act:
1. Where manufacturing facilities are installed in buildings newly constructed, documents verifying the ownership of land (where the ownership can be verified with a certified copy of the land register, such verification shall be in lieu of the attached documents) or a copy of a lease contract;
2. Where manufacturing facilities are installed in the existing buildings, documents verifying the ownership of such buildings (where the ownership can be verified with a certified copy of the building register, such verification shall be in lieu of the attached documents) or a copy of a lease contract;
3. The documents referred to in the subparagraphs of Article 3 (1).
(2) A person who intends to obtain conditional manufacturing permission under Article 7 (1) of the Act shall submit an application in attached Form 3 (including an application in electronic form) to the Minister of Food and Drug Safety, along with the documents referred to in Article 5 (1) 2 (including electronic documents).
(3) A person who intends to obtain conditional manufacturing certification under Article 7 (1) of the Act shall submit an application in attached Form 5 (including an application in electronic form) to the head of the Information Institute, along with the documents referred to in Article 5 (1) 2 (including electronic documents). <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(4) A person who intends to file a conditional manufacturing notification under Article 7 (1) of the Act shall submit a notification in attached Form 7 (including a notification in electronic form) to the head of the Information Institute. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(5) Upon granting conditional manufacturing business permission, conditional manufacturing permission, or conditional manufacturing certification, or upon receipt of a conditional manufacturing notification, the Minister of Food and Drug Safety, the head of a regional office of food and drug safety, or the head of the Information Institute shall state the matters prescribed in Articles 3 (3), 5 (2), 6 (2), or 7 (2) and the conditions of permission, certification, or notification in the manufacturing business permission register, manufacturing permission register, manufacturing certification register, or manufacturing notification register; and shall issue a conditional permit for manufacturing business in attached Form 13, a conditional permit for manufacturing in attached Form 14, or a conditional certificate of manufacturing in attached Form 15. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
 Article 17 (Notification and Verification of Compliance with Conditions)
(1) Where a person who has obtained conditional permission or certification or has filed a conditional notification under Article 16 complies with the conditions of permission, certification, or notification, he or she shall submit documents evidencing such compliance to the Minister of Food and Drug Safety, the head of a regional office of food and drug safety having jurisdiction over the location of a factory, or the head of the Infor mation Institute. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(2) Upon receipt of the documents prescribed in paragraph (1), the Minister of Food and Drug Safety, the head of a regional office of food and drug safety, or the head of the Information Institute shall verify whether the relevant conditions are complied with within 20 days from the date of submission of such documents; issue a manufacturing business permit under Article 3 (3), a manufacturing permit under Article 5 (2), or a manufacturing certificate under Article 6 (2) instead of a conditional permit for manufacturing business, a conditional permit for manufacturing, or a conditional certificate of manufacturing under Article 16 (5), respectively; and enter the date of compliance with the conditions in the notification register. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
 Article 18 (Application for Re-Review)
(1) Where the Minister of Food and Drug Safety issues an order to undergo re-review while granting manufacturing permission under Article 8 (1) of the Act, he or she shall state the period of application for re-review in the relevant manufacturing permit.
(2) A person who applies for re-review under Article 8 (2) of the Act shall submit an application in attached Form 16 (including an application in electronic form) to the Minister of Food and Drug Safety within the period of application for re-review under paragraph (1), along with the following data (including data in electronic form):
1. Data regarding the investigation of domestic post-market safety and effectiveness;
2. Domestic and foreign data regarding side effects and safety;
3. Data regarding the current status of domestic and international sales and the current status of permission in foreign countries.
(3) Upon receipt of an application for re-review under paragraph (2), the Minister of Food and Drug Safety shall re-review the relevant item after deliberation by the Medical Devices Committee established under Article 5 (1) of the Act (hereinafter referred to as the “Medical Devices Committee”) within six months from the date of application, and shall notify the applicant of the results as prepared in attached Form 17.
(4) A manufacturer who is notified of the results of re-review under paragraph (3) shall take measures based on such results within 30 days from the date of notice.
(5) The Minister of Food and Drug Safety shall determine and publicly notify the guidelines for preparing attached documents in applying for re-review, requirements for each document, scope of exemption, scope of and standards for review, and other details.
 Article 19 (Methods and Procedures for Re-Evaluation)
(1) Where the Minister of Food and Drug Safety intends to re-evaluate medical devices pursuant to Article 9 of the Act, he or she shall determine items subject to re-evaluation after deliberation by the Medical Devices Committee and publicly announce the following matters on the website of the Ministry of Food and Drug Safety:
1. Items subject to re-evaluation;
2. The period for applying for re-evaluation;
3. The details of submitted data necessary for re-evaluation.
(2) A manufacturer of medical devices falling under the items subject to re-evaluation shall submit an application for re-evaluation of medical devices in attached Form 18 (including an application in electronic form) to the Minister of Food and Drug Safety during the period of application for re-evaluation under paragraph (1) 2, along with the data referred to in paragraph (1) 3 (including data in electronic form).
(3) The Minister of Food and D rug Safety upon receipt of an application for re-evaluation under paragraph (2) shall re-evaluate the relevant items, allow the perusal of the draft results of re-evaluation for at least one month so as to provide the opportunity for a manufacturer of the relevant items subject to re-evaluation to provide an opinion on such results and publicly announce the results of re-evaluation on the website of the Ministry of Food and Drug Safety.
(4) Details regarding the guidelines for preparing data to be submitted, the requirements for each data and the scope of exemption, the scope of re-evaluation and standards for conducting re-evaluation, etc. under paragraphs (2) and (3) shall be determined and publicly notified by the Minister of Food and Drug Safety.
 Article 20 (Approval of Clinical Trial Protocols)
(1) A person who intends to obtain approval of a clinical trial protocol pursuant to Article 10 (1) of the Act or a person who intends to modify the approved clinical trial protocol shall submit to the Minister of Food and Drug Safety an application for approval of a clinical trial protocol in attached Form 19 (including an application in electronic form) or an application for approval of modification of a clinical trial protocol in attached Form 20 (including an application in electronic form) and a written approval of a clinical trial protocol, respectively, along with the following documents (including electronic documents) and data (including data in electronic form): Provided, That where the person applies for approval of modification of the clinical trial protocol, he or she need not submit data referred to in subparagraphs 2 and 3, as determined and publicly notified by the Minister of Food and Drug Safety: <Amended by Ordinance of the Prime Minister No. 1567, Oct. 22, 2019>
1. A clinical trial protocol or a modified clinical trial protocol;
2. Data evidencing that medical devices for clinical trials are manufactured in compliance with the standards for facilities and manufacturing and quality management systems under attached Table 2;
3. Data referred to in Article 9 (2) 2 through 5: Provided, That in cases of in vitro diagnostic medical devices, data referred to in the subparagraphs of Article 9 (3) (excluding data about clinical performance studies) shall be submitted.
(2) A clinical trial protocol under paragraph (1) 1 shall include the following matters:
1. The titles of clinical trials;
2. The name and location of a clinical trial institution;
3. The names and positions of clinical trial principal investigator and subinvestigators and joint researchers;
4. The name and position of a person who manages medical devices for clinical trials;
5. The name and address of a person who intends to conduct a clinical trial;
6. The objectives and background of clinical trials;
7. The outlines of medical devices for clinical trials (including the intended uses, relevant illnesses, or indications for use);
8. The standards for selection and exclusion of, and the number of, persons who are subject to the application of medical devices for clinical trials or persons who participate in clinical trials as a control group (hereinafter referred to as "subjects"), and the grounds therefor;
9. The periods for clinical trials;
10. The methods for clinical trials (including usage, methods for use, periods of use, combination therapy, etc.);
11. Items of observation, items of clinical studies, and methods for observational studies;
12. Expected side effects and precautions for use;
13. The standards for suspension and drop-out;
14. The standards and methods for evaluating effectiveness and the methods for interpreting effectiveness (based on the methods for statistical analysis);
15. The standards and methods for evaluating safety, including side effects, and the reporting methods;
16. The form of a written consent from a subject;
17. The agreement on compensations for victims;
18. Matters regarding the treatment of subjects after conducting clinical trials;
19. Measures to protect the safety of subjects;
20. Other matters necessary to conduct clinical trials in a safe and scientific manner.
(3) Any of the following trials shall be excluded from approval from the Minister of Food and Drug Safety under Article 10 of the Act:
1. A trial for observing clinical effects and investigating adverse events regarding the permitted matters of medical devices on the market;
2. A trial for collecting data about safety and effectiveness regarding the permitted performance and intended uses of medical devices on the market;
3. A trial for in vitro diagnostic medical devices, which is determined by the Minister of Food and Drug Safety;
4. Any other trial using medical devices on the market, which is determined by the Minister of Food and Drug Safety as there is no direct correlation with safety or it is not likely to cause ethical problems.
(4) Where an application for approval of a clinical trial protocol submitted under paragraph (1) is deemed appropriate following the review thereof, the Minister of Food and Drug Safety shall issue a written approval of a clinical trial protocol in attached Form 21 to the applicant, and where the Minister approves the modification of the clinical trial protocol, he or she shall state the modified matters in the columns for modification and disposition in the written approval.
(5) Details regarding the guidelines for preparing data to be submitted in applying for approval of a clinical trial protocol or approval of modification thereof, the scope of data to be exempt, the requirements, standards, and procedures for approval, etc. under paragraphs (1) through (4) shall be determined and publicly notified by the Minister of Food and Drug Safety.
 Article 21 (Standards and Procedures for Designating Clinical Trial Institution)
(1) A clinical trial institution under Article 10 (3) of the Act (hereinafter referred to as "clinical trial institution") shall be any of the following medical institutions:
1. A general hospital under Article 3 (2) 3 (e) of the Medical Service Act;
2. A training hospital, training dental clinic, or oriental medical hospital under the Regulations on the Training and Recognition, etc. of Qualifications of Medical Specialists, the Regulations on the Training and Recognition, etc. of Qualifications of Dentists, or the Regulations on the Training and Recognition, etc. of Qualifications of Oriental Medical Doctors;
3. A specialized hospital designated pursuant to Article 3-5 of the Medical Service Act;
4. A hospital with personnel, facilities, etc. meeting the standards for designating a training hospital or training dental clinic to train a single specialization under Article 7 (3) 2 of the Regulations on the Training and Recognition, etc. of Qualifications of Medical Specialists or Article 7 (2) 2 of the Regulations on the Training and Recognition, etc. of Qualifications of Dentists;
5. A clinical trial center in a high-tech medical complex designated pursuant to the Special Act on the Designation and Support of High-Tech Medical Complexes.
(2) A person who intends to be designated as a clinical trial institution shall submit an application for designation as a clinical trial institution for medical devices in attached Form 22 (including an application in electronic form) to the Minister of Food and Drug Safety, along with the following documents (including electronic documents):
1. Deleted; <by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
2. Regulations on administrative procedures, etc. necessary for clinical trials;
3. Regulations on the operation of an institutional review board for clinical trials under subparagraph 6 of attached Table 3 and documents regarding the organization thereof (in cases of review entrusted to an outside designated institutional review board under item (e) of that subparagraph, a contract for entrustment shall be attached thereto);
4. Regulations on entrusted review, where the person intends to operate a designated institutional review board pursuant to subparagraph 6 (e) of attached Table 3 to be entrusted with review of clinical trials conducted by another clinical trial institution;
5. Documents evidencing that the person falls under any of the subparagraphs of paragraph (1).
(3) Upon receipt of an application under paragraph (2), the public official in charge shall verify a corporation registration certificate (limited to a corporation) and a permit for opening a medical institution through administrative data matching under Article 36 (1) of the Electronic Government Act: Provided, That where an applicant does not consent to the verification of the permit for opening a medical institution, such applicant shall attach a copy thereof. <Amended by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
(4) Upon receipt of an application under paragraph (2), the Minister of Food and Drug Safety may conduct a fact-finding survey to evaluate whether the details of such application meet the standards for designation.
(5) Where the Minister of Food and Drug Safety designates a clinical trial institution, he or she shall issue a certificate of designation as a clinical trial institution for medical devices in attached Form 23 to the applicant.
(6) Where a clinical trial institution intends to modify designated matters, it shall submit an application for modification of designation as a clinical trial institution for medical devices in attached Form 24 to the Minister of Food and Drug Safety within 30 days from the date reasons for such modification occur, along with a certificate of designation as a clinical trial institution for medical devices and documents verifying modified matters.
(7) Where the Minister of Food and Drug Safety modifies designation of a clinical trial institution, he or she shall state the modified matters in a certificate of designation as a clinical trial institution for medical devices.
(8) Where the Minister of Food and Drug Safety designates a clinical trial institution or modifies designation thereof pursuant to paragraph (5) or (7), he or she shall publicly announce the name, location, representative, etc. of the clinical trial institution on the website, etc.
(9) Details necessary for the designation, operation, management, etc. of a clinical trial institution shall be determined and publicly notified by the Minister of Food and Drug Safety.
 Article 22 (Collective Facilities)
"Collective facility prescribed by Ordinance of the Prime Minister, such as a social welfare facility" in the main clause of Article 10 (4) 2 of the Act means any of the following facilities: <Amended by Ordinance of the Prime Minister No. 1542, Jun. 12, 2019>
1. Child welfare facilities under Article 52 (1) 1, 2, 3, and 5 of the Child Welfare Act;
2. Residential homes for persons with disabilities under Article 58 (1) 1 of the Act on Welfare of Persons with Disabilities;
3. Mental health improvement facilities under subparagraph 4 of Article 3 of the Act on the Improvement of Mental Health and the Support for Welfare Services for Mental Patients (limited to those with protection rooms, in cases of mental medical institutions);
4. Residential welfare institutions for senior citizens (excluding welfare houses for senior citizens) and medical and welfare institutions for senior citizens (excluding geriatric hospitals) established pursuant to Article 34 of the Social Welfare Services Act;
5. Welfare institutions for senior citizens under Article 32 (1) 1 and 2 of the Welfare of Senior Citizens Act and Article 34 (1) 1 and 2 of that Act;
6. Mother-and-child family welfare facilities (support for basic living and self-support living), father-and-child family welfare facilities (support for basic living and self-support living), unmarried mother-and-child family welfare facilities (support for basic living), and temporary supporting welfare facilities under Article 19 of the Single-Parent Family Support Act;
7. Support facilities for victims, etc. of commercial sex acts under Article 9 (1) 1 and 2 of the Act on the Prevention of Commercial Sex Acts and Protection, etc. of Victims;
8. Protection facilities for victims of sexual violence under Article 12 of the Sexual Violence Prevention and Victims Protection Act;
9. Shelters for victims of domestic violence under Article 7 of the Act on the Prevention of Domestic Violence and Protection, etc. of Victims;
10. Facilities established by a person who obtains permission for a rehabilitation service pursuant to Article 67 of the Act on Probation, Etc. (limited to those with committal facilities);
11. Correctional facilities under the Administration and Treatment of Correctional Institution Inmates Act and the Act on the Execution of Criminal Penalties in the Armed Forces and the Treatment of the Military Inmates;
12. Juvenile reformatories and Juvenile Classification Review Boards under the Act on the Treatment of Protected Juveniles, Etc.;
13. Detention facilities under Article 52 (2) of the Immigration Act.
 Article 23 Deleted. <by Ordinance of the Prime Minister No. 1284, Jun. 15, 2016>
 Article 24 (Standards for Conducting Clinical Trials)
(1) Pursuant to Article 10 (7) of the Act, clinical trials shall be conducted according to the following standards and the Good Clinical Practice for medical devices specified in attached Table 3:
1. Clinical trials shall be conducted in a safe and scientific manner according to a clinical trial protocol;
2. Clinical trials shall be conducted in a clinical trial institution designated by the Minister of Food and Drug Safety;
3. Clinical trial principal investigators shall be selected from among those with expertise, ethical discipline, and considerable experience in conducting clinical trials of the relevant medical devices;
4. An explanation shall be provided to subjects of clinical trials regarding clinical trial details and the details of and procedures for compensation for potential harms that could affect the health of the subjects during the clinical trials and other relevant matters, and a written consent shall be obtained from the subjects: Provided, That where it is impracticable to obtain consent from a subject due to his or her lack of ability of understanding and communication or due to other reasons, consent shall be obtained from a person with parental authority, guardian, etc.;
5. Safety measures for the subjects of clinical trials shall be prepared;
6. Medical devices for clinical trials shall not be used for purposes other than clinical trials: Provided, That the same shall not apply to cases prescribed by the Minister of Food and Drug Safety, such as where the medical devices are used for patients with critical illnesses that threaten life, including terminal cancer;
7. Clinical trials shall be commenced within two years from the date of obtaining approval of a clinical trial protocol or approval of modification thereof;
8. Clinical trial investigators shall be provided with clinical trial data books before conducting the clinical trials, as determined by the Minister of Food and Drug Safety;
9. Where new data, information, etc. on safety and effectiveness is obtained, such fact shall be notified to clinical trial investigators without delay, and whether to reflect it shall be examined;
10. Medical devices for clinical trials that are appropriately manufactured according to the standards for facilities and manufacturing and quality management systems under attached Table 2 shall be used;
11. Where adverse events occur while using a medical device, a person who obtains approval of a clinical trial protocol shall report them to the Minister of Food and Drug Safety according to the Good Clinical Practice for medical devices specified in attached Table 3;
12. Specimens shall be provided on condition of anonymity where clinical trials are conducted using the following specimens (hereinafter referred to as "remaining specimen") and any consent under subparagraph 4 is not obtained:
(a) Human-derived specimens remaining after being used for the purpose of diagnosis or treatment at a medical institution;
(b) Human-derived specimens remaining after being collected and used for specific research purposes, for which a specimen provider has given a comprehensive consent to the secondary use of specimens for other purposes;
13. Other matters determined by the Minister of Food and Drug Safety to properly conduct a clinical trial shall be observed.
(2) Regarding the status of conducting a clinical trial, a person who has obtained approval of a clinical trial protocol shall submit a report in attached Form 25 (including a report in electronic form) to the Minister of Food and Drug Safety by the end of February each year, along with summarized data related to the safety evaluation of medical devices for clinical trials under subparagraph 8 (q) (i) of attached Table 3; and where the clinical trial is completed, he or she shall submit a report in attached Form 26 (including a report in electronic form) to the Minister of Food and Drug Safety within 20 days from the date of completion. <Amended by Ordinance of the Prime Minister No. 1567, Oct. 22, 2019>
(3) A clinical trial sponsor or the head of a clinical trial institution shall retain the clinical trial protocol and the records and data regarding the conducting of clinical trials (including electronic documents) for the periods classified as follows:
1. Data related to clinical trials for manufacturing or import permission, or permission for modification thereof: Three years from the date of permission;
2. Other data related to clinical trials: Three years from the date of completion of clinical trials.
(4) Notwithstanding the main clause of paragraph (1) 4, a clinical trial may be conducted without consent from the subjects of the clinical trial by obtaining approval from an institutional review board for clinical trials, in cases of a clinical trial using remaining specimens and satisfying all the following requirements: Provided, That the same shall not apply where consent from a person with parental authority, guardian, etc. shall be obtained pursuant to the proviso of paragraph (1) 4:
1. Where it is impracticable to obtain consent from a subject of the clinical trial;
2. Where no compelling reason exists for the subjects to refuse consent, and even without the consent from the subjects, it is highly unlikely that the clinical trial would place them at risk.
(5) Details regarding the standards, etc. for designating clinical trial institutions under paragraph (1) shall be determined and publicly notified by the Minister of Food and Drug Safety.
 Article 24-2 (Designation of Institutions Conducting Non-Clinical Studies)
(1) A person who intends to be designated as an institution conducting non-clinical studies pursuant to Article 10-2 (1) of the Act shall satisfy the standards for designation determined and publicly notified by the Minister of Food and Drug Safety, such as specialized personnel, facilities, and instruments necessary for each area of non-clinical studies.
(2) A person who intends to be designated as an institution conducting non-clinical studies shall submit an application for designation as an institution conducting non-clinical studies of medical devices in attached Form 26-2 (including an application in electronic form) to the Minister of Food and Drug Safety, along with the following documents (including electronic documents):
1. Documents regarding the current status of the organization and personnel (including documents evidencing qualifications and work experience, in cases of personnel status);
2. Documents regarding the current status of equipment, instruments, and facilities;
3. Documents evidencing that non-clinical studies have been conducted as determined and publicly notified by the Minister of Food and Drug Safety, to evidence that it has capabilities to conduct non-clinical studies.
(3) Upon receipt of an application under paragraph (2), the Minister of Food and Drug Safety may conduct a fact-finding survey to evaluate whether the details of such application meet the standards for designation.
(4) Where the Minister of Food and Drug Safety designates an institution conducting non-clinical studies, he or she shall issue the applicant with a certificate of designation as an institution conducting non-clinical studies of medical devices in attached Form 26-3.
(5) Where an institution conducting non-clinical studies intends to modify any of the following matters, it shall submit an application for modification of designated matters of an institution conducting non-clinical studies of medical devices in attached Form 26-4 (including an application in electronic form) to the Minister of Food and Drug Safety within 30 days from the date reasons for such modification occur, along with a certificate of designation as an institution conducting non-clinical studies of medical devices and documents verifying the modified matters (including electronic documents):
1. The representative and operating officers of the institution conducting non-clinical studies;
2. The name and location of the institution conducting non-clinical studies;
3. Areas of non-clinical studies.
(6) Where the Minister of Food and Drug Safety modifies designation of an institution conducting non-clinical studies, he or she shall state the modified matters in a certificate of designation as an institution conducting non-clinical studies of medical devices and issue such certificate.
(7) Where the Minister of Food and Drug Safety designates an institution conducting non-clinical studies or modifies such designation, he or she shall publicly announce the name, location, representative, etc. of the institution conducting non-clinical studies on the website, etc. of the Ministry of Food and Drug Safety.
(8) Details regarding the scope of documents to be submitted pursuant to paragraph (2) shall be determined and publicly notified by the Minister of Food and Drug Safety.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1389, May 1, 2017]
 Article 24-3 (Matters to Be Observed by Institutions Conducting Non-Clinical Studies)
"Matters prescribed by Ordinance of the Prime Minister" in Article 10-2 (3) of the Act means the following matters:
1. Preparing a non-clinical study protocol and conducting non-clinical studies according to such protocol;
2. Requiring a person not associated with the relevant non-clinical study to conduct an inspection or audit in order to ensure credibility in non-clinical studies;
3. Evidencing that a non-clinical study has been conducted in compliance with the Good Clinical Practice for non-clinical studies determined and publicly notified by the Minister of Food and Drug Safety;
4. Retaining data and records related to non-clinical studies for the periods classified as follows:
(a) Studies for permission for medical devices or permission for modification thereof, or studies for certification of medical devices or certification of modification thereof: Five years from the date of issuance of a non-clinical study report;
(b) Studies for other purposes: Three years from the date of issuance of a non-clinical study report.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1389, May 1, 2017]
 Article 25 (Subject Matters of Preliminary Examinations)
(1) Subject matters and scope of a preliminary examination under Article 11 of the Act shall be as follows:
1. Matters regarding technical documents, etc. of newly-developed medical devices or orphan medical devices under the subparagraphs of Article 8 (1) of the Act;
2. Other matters regarding technical documents, etc. of medical devices for which the Minister of Food and Drug Safety deems that preliminary examinations are necessary.
(2) A person who intends to request a preliminary examination pursuant to Article 11 of the Act shall submit an application for a preliminary examination of medical devices in attached Form 27 (including an application in electronic form) to the Minister of Food and Drug Safety or the head of the Information Institute according to the following classifications: <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
1. A person who intends to obtain manufacturing permission of medical devices pursuant to Article 6 (2) of the Act or to undergo a clinical trial pursuant to Article 10 of the Act: The Minister of Food and Drug Safety;
2. A person who intends to obtain manufacturing certification or to file a manufacturing notification: The head of the Information Institute.
(3) The Minister of Food and Drug Safety or the head of the Information Institute shall inform the applicant of the results of a preliminary examination as prepared in a notice of the results of a preliminary examination of medical devices in attached Form 28. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(4) Except as provided in paragraphs (1) through (3), details necessary for the procedures, methods, etc. for preliminary examinations shall be determined and publicly notified by the Minister of Food and Drug Safety.
 Article 26 (Application for Permission for Modification of Permitted Matters)
(1) Pursuant to Article 12 (1) of the Act, where any modification is made to matters for which manufacturing business permission is granted, a manufacturer shall submit an application for permission for modification in attached Form 29 (including an application in electronic form) to the head of a regional office of food and drug safety within 30 days from the date such modification is made, along with the data classified as follows (including data in electronic form):
1. Where the location of a factory is modified or another factory is added, a copy of a contract for entrustment (limited to cases of entrusting the manufacturing processes or testing, and including data in electronic form) and data evidencing the compliance with the standards for facilities and manufacturing and quality management systems under attached Table 2;
2. Where a quality manager is replaced, data verifying the qualifications under Article 11 (2) of the replaced quality manager.
(2) The head of a regional office of food and drug safety upon receipt of an application under paragraph (1) shall verify a corporation registration certificate (limited to a corporation) through administrative data matching under Article 36 (1) of the Electronic Government Act. <Amended by Ordinance of the Prime Minister No. 1284, Jun. 15, 2016>
(3) Pursuant to Article 12 (1) of the Act, where any modification is made to matters regarding manufacturing permission or manufacturing certification granted or a manufacturing notification filed, a manufacturer shall submit an application for permission for modification in attached Form 30 (including an application in electronic form) to the Minister of Food and Drug Safety, and submit an application for certification of modification in attached Form 31 (including an application in electronic form) or a notification in attached Form 7 (including a notification in electronic form) to the head of the Information Institute, respectively, along with the following documents (including electronic documents): <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
1. Documents verifying modified matters (including electronic documents);
2. Documents under Article 5 (1) 2, when modification is made to any important matter that affects the safety or effectiveness of products, such as the design, materials, chemical components, energy sources, and manufacturing processes of medical devices;
3. A copy of a contract for entrustment (limited to cases of entrusting the manufacturing processes or testing, and including data in electronic form) and data evidencing the compliance with the standards for facilities and manufacturing and quality management systems under attached Table 2, where the location of a factory of the relevant item is modified or another factory is added.
(4) Where a person to whom the relevant manufacturing facilities, methods, etc. are transferred as a consequence of the division, merger, etc. of a company obtains permission for or certification of modification of the manufactured item or files a notification of modification thereof pursuant to paragraph (3), he or she shall submit the relevant application or notification to the Minister of Food and Drug Safety or the head of the Information Institute, along with a transfer or acquisition contract regarding the manufacturing facilities, methods, etc. of the relevant item. In such cases, where permission for or certification of modification of the relevant item is granted, conditions equivalent to those on permission or certification for a transferor may be attached. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(5) Where matters modified pursuant to paragraph (3) pertain to the external appearance, packaging materials, packaging unit, etc. of a manufactured item and are minor matters determined and publicly notified by the Minister of Food and Drug Safety, documents stating the details of modification (including electronic documents) shall be submitted to the Minister of Food and Drug Safety or the head of the Information Institute, notwithstanding that paragraph. In such cases, permission for or certification of modification or a notification of modification under Article 12 of the Act shall be deemed obtained or filed. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(6) In any of the following cases where any modification is made to matters permitted, certified, or notified, permission for or certification of modification or a notification of modification under Article 12 of the Act shall be deemed obtained or filed: Provided, That in cases falling under subparagraph 3, 4, or 6, the same shall apply only where any modification is made after an order of modification is issued by a certain time limit pursuant to Article 36 (2) of the Act:
1. Modification of the standards for the classification and designation of classes under Article 3 of the Act;
2. Modification of technical documents or clinical trial data under Article 6 (5) of the Act;
3. Re-review of newly-developed medical devices, etc. under Article 8 of the Act;
4. Re-evaluation under Article 9 of the Act;
5. Modification of standard specifications under Article 19 of the Act;
6. Measures taken following reporting on side effects under Article 31 of the Act.
(7) Where the Minister of Food and Drug Safety, the head of a regional office of food and drug safety, or the head of the Information Institute grants permission for or certification of modification or accepts a notification of modification pursuant to paragraphs (1) through (6), he or she shall enter the modified matters in the relevant register. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(8) Details regarding the standards and procedures for permission, certification, or notification of modification, the requirements for, scope of exemption of, and management of data, and other matters under paragraphs (1) through (7) shall be determined and publicly notified by the Minister of Food and Drug Safety.
 Article 27 (Matters to Be Observed by Manufacturers)
(1) Matters to be observed by medical device manufacturers pursuant to Article 13 (1) of the Act shall be as follows:
1. Manufacturers shall manage the facilities of factories in a sanitary manner not to cause any harm to health and hygiene, and shall prevent cross-contamination or contamination, etc. from the outside;
2. Manufacturers shall not place objects likely to cause harm in working places, and shall prevent substances hazardous to public health from being discharged or released from working places;
3. Manufacturers shall prepare and keep documents about warehousing and release of raw materials and finished products, manufacturing processes, and quality management (including testing standards and methods, etc.), and shall thoroughly conduct manufacturing and quality inspections based on such documents;
4. Manufacturers shall prepare and keep the records of manufacturing and quality inspections under subparagraph 3 by manufacturing unit and the records of handling customers' complaints, and shall retain such records for five years from the date of manufacturing (referring to a period corresponding to the product life cycle, where such life cycle exceeds five years);
5. Where the safety and effectiveness of released medical devices are undermined or the quality thereof is poor, manufacturers shall take corrective measures, such as recall without delay;
6. Manufacturers shall release sterile products after verifying that they have been packaged and sterilized using new containers;
7. Manufacturers shall release electronic or mechanical products after ensuring their electronic and mechanical safety and electromagnetic safety;
8. Manufacturers shall release products in direct or indirect contact with the human body after ensuring their biological safety;
9. Where manufacturers are aware of new data or information on the safety and effectiveness of medical devices permitted, certified, or notified (including cases of side effects following the use of the medical device), they shall report it and prepare necessary safety measures as determined by the Minister of Food and Drug Safety;
10. Manufacturers shall maintain the standards for facilities and manufacturing and quality management systems under attached Table 2;
11. Manufacturers shall distribute medical devices manufactured in compliance with the standards under subparagraph 2 of attached Table 2. In such cases, medical devices manufactured for the purpose of the recognition of compliance pursuant to subparagraph 2 (f) of attached Table 2 and recognized as compliant pursuant to that item shall be deemed manufactured after being recognized as compliant pursuant to that item;
12. Manufacturers shall conduct manufacturing and quality management or production management by applying the latest standard specifications determined by the Minister of Food and Drug Safety pursuant to Article 19 of the Act;
13. Manufacturers shall thoroughly inspect the hygiene of employees and provide them with education and training necessary to produce medical devices with excellent quality;
14. Manufacturers shall thoroughly conduct the affairs of post-market safety management, such as re-review, re-evaluation, management of medical devices subject to tracking management, and management of safety information (including the management of reports on side effects);
15. Where manufacturers purchase medical devices manufactured by their company from medical institutions, they shall observe the following:
(a) They shall inspect whether such medical devices are in compliance with the standards for manufacturing and quality management systems for medical devices under subparagraph 2 of attached Table 2 and release them with certificates of inspection attached thereto only if they are in compliance with such standards;
(b) They shall prepare and keep the records of the details and results of inspections under item (a), the dates of issuing certificates of inspection, etc., and shall retain such records for two years from the relevant date of release;
16. Where manufacturers are requested to conduct inspections by medical device distributors or lessors pursuant to subparagraph 1 (a) of Article 39, they shall observe the following:
(a) They shall inspect whether medical devices are in compliance with the standards for manufacturing and quality management systems for medical devices under subparagraph 2 of attached Table 2 and issue certificates of inspection only if they are in compliance with such standards;
(b) They shall observe the matters determined and publicly notified by the Minister of Food and Drug Safety regarding the procedures and methods for issuing certificates of inspection, the period of reply, instructions about distribution or lease, etc.
(2) Manufacturers shall report on the results of producing and exporting medical devices for the pertinent year to the Minister of Health and Welfare and the Minister of Food and Drug Safety pursuant to Article 13 (2) of the Act, as determined and publicly notified by the Minister of Food and Drug Safety.
 Article 28 (Notification of Business Closure)
(1) Where a manufacturer intends to file a notification of business closure or business suspension pursuant to Article 14 of the Act, he or she shall submit a notification in attached Form 32 (including a notification in electronic form) to the head of a regional office of food and drug safety having jurisdiction over the location of a factory, along with the following documents; and where a person who has suspended his or her business intends to file a notification of business resumption, he or she shall submit a notification in attached Form 32 (including a notification in electronic form) to the head of a regional office of food and drug safety having jurisdiction over the location of the factory:
1. In cases of business closure: A manufacturing business permit and all the manufacturing permits and certificates;
2. In cases of business suspension: A manufacturing business permit.
(2) Upon receipt of a notification of business closure under paragraph (1), the head of a regional office of food and drug safety shall enter such details in the manufacturing business permission register; and upon receipt of a notification of business suspension or resumption, he or she shall enter the details in the manufacturing business permission register and a manufacturing business permit, respectively.
(3) Where the head of a tax office having jurisdiction over the location of a factory receives a notification of business closure or business suspension and forwards it to the head of the competent regional office of food and drug safety pursuant to Article 13 (5) of the Enforcement Decree of the Value-Added Tax Act, a notification of business closure or business suspension under paragraph (1) shall be deemed submitted.
 Article 29 (Application for Import Business Permission)
(1) A person who intends to obtain import business permission of medical devices pursuant to Article 15 (1) of the Act shall submit an application in attached Form 1 (including an application in electronic form) to the head of a regional office of food and drug safety having jurisdiction over the location of an import business place, along with documents referred to in the subparagraphs of Article 3 (1) (including electronic documents).
(2) The head of a regional office of food and drug safety upon receipt of an application under paragraph (1) shall verify a corporation registration certificate (limited to a corporation) through administrative data matching under Article 36 (1) of the Electronic Government Act.
 Article 30 (Application for Import Permission)
(1) A person who intends to obtain import permission of medical devices pursuant to Article 15 (2) of the Act shall submit an application in attached Form 3 (including an application in electronic form) to the Minister of Food and Drug Safety, along with the following documents (including electronic documents):
1. Documents referred to in Article 5 (1) 2: Provided, That such documents may be omitted where it is evidenced that medical devices to be imported are the same products with the same origin of manufacture (referring to the same country of manufacture, manufacturing company, and factory) as medical devices already permitted, as determined by the Minister of Food and Drug Safety;
2. Documents evidencing that a factory of medical devices to be imported has the manufacturing and quality management systems under Article 15 (4) of the Act.
(2) A person who intends to obtain import certification of medical devices pursuant to Article 15 (2) of the Act shall submit an application in attached Form 5 (including an application in electronic form) to the head of the Information Institute, along with documents referred to in the subparagraphs of paragraph (1) (including electronic documents). In such cases, "permitted" in the proviso of paragraph (1) 1 shall be deemed "certified". <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(3) A person who intends to file an import notification of medical devices pursuant to Article 15 (2) of the Act shall submit a notification in attached Form 7 (including a notification in electronic form) to the head of the Information Institute. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
 Article 31 (Standards for Facilities and Manufacturing and Quality Management Systems for Quality Inspections)
(1) A person who intends to obtain import business permission or a person who intends to obtain import permission or import certification or to file an import notification pursuant to the main clause of Article 15 (4) of the Act shall prepare the standards for facilities and manufacturing and quality management systems as specified in attached Table 4.
(2) "Cases prescribed by Ordinance of the Prime Minister, such as entrusting quality management testing" in the proviso of Article 15 (4) of the Act means where a person who intends to obtain import business permission or a person who intends to obtain import permission or import certification or to file an import notification entrusts quality management testing to any of the following persons. In such cases, such person need not be equipped with laboratories or testing facilities under subparagraph 1 (c) of attached Table 4: <Amended by Ordinance of the Prime Minister No. 1389, May 1, 2017>
1. A medical device testing and inspection institution;
1-2. An institution conducting non-clinical studies;
2. A manufacturer whose compliance has been recognized pursuant to subparagraph 2 (f) of attached Table 2.
 Article 32 (Exemption from Permission for Medical Device Import Business)
(1) Medical devices that may be imported without obtaining import business permission, import permission, or import certification or without filing an import notification pursuant to Article 6 (10) of the Act applied mutatis mutandis in accordance with Article 15 (6) of the Act shall be as follows: <Amended by Ordinance of the Prime Minister No. 1284, Jun. 15, 2016; Ordinance of the Prime Minister No. 1469, Jun. 14, 2018; Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
1. A medical device subject to clinical trials, for which approval of a clinical trial protocol is granted pursuant to the main clause of Article 10 (1) of the Act;
2. A separate medical device necessary for clinical trials, for which approval of a clinical trial protocol need not be granted pursuant to the proviso of Article 10 (1) of the Act;
3. A separate medical device necessary for clinical trials regarding drugs, etc., for which approval of a clinical trial protocol shall be granted pursuant to Article 34 of the Pharmaceutical Affairs Act;
4. A medical device imported to obtain import permission or certification of medical devices or to file an import notification thereof;
5. A medical device used for the purpose of research, such as product development;
5-2. A medical device not for the purpose of distribution, which is imported to help consumers purchase a product, such as checking the actual appearance of the product;
5-3. A medical device imported to conduct testing and inspections under Article 27 of the Act;
6. A medical device determined and publicly notified by the Minister of Food and Drug Safety, such as a medical device for self-use or relief operations;
7. Deleted; <by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
8. A medical device determined and publicly notified by the Minister of Food and Drug Safety, which is used in clinical laboratories deemed suitable by the Minister based on the evaluations of quality management systems, inspection performance and competence, etc.
(2) Matters regarding the import procedures, subject matters, issuance of a certificate, etc. of medical devices excluded from those subject to import business permission and import permission, certification, or notification pursuant to paragraph (1) shall be determined and publicly notified by the Minister of Food and Drug Safety.
 Article 33 (Matters to Be Observed by Importers)
(1) Matters to be observed by a medical device importer under Article 13 (1) of the Act applied mutatis mutandis in accordance with Article 15 (6) of the Act shall be as follows:
1. The importer shall manage the facilities of an import business place in a sanitary manner not to cause any harm to health or hygiene and prevent cross-contamination or contamination, etc. from the outside;
2. The importer shall prepare and keep documents regarding the warehousing and release, and quality management of medical devices (including testing standards and methods, labeling, packaging, etc.) and management records on storage and shipment of accessories, and shall thoroughly conduct import and quality inspections based on such documents and records;
3. The importer shall prepare and keep the records of import and quality inspections under subparagraph 2 by import unit and the records of handling customers’ complaints, and shall retain such records for five years from the date of import (referring to a period corresponding to the product life cycle, where the product life cycle exceeds five years);
4. The importer shall release sterile products after verifying that the products have been sterilized;
5. The importer shall release electronic or mechanical products after ensuring their electronic and mechanical safety and electromagnetic safety;
6. The importer shall release products in direct or indirect contact with the human body after ensuring their biological safety;
7. The importer shall prepare and keep a manual of product specifications by item including the following matters:
(a) The name of a medical device (the product name, item name, and model name);
(b) The name of a manufacturing company of an imported medical device and a country of manufacture thereof;
(c) Self-quality-management-test specifications of shapes, structures, and finished products;
(d) Matters to be stated on the container, etc. of a medical device, as prescribed in Articles 20 through 23 of the Act;
(e) The method for and order of installation (limited to medical devices whose installation management is required);
(f) Matters regarding sterilization methods and standards, and assessment (limited to sterile medical devices);
(g) The presenter and presentation date of a manual of product specifications (if revised, a person who revises and the date and cause of revision shall be stated);
8. The importer shall prepare and keep import management standards including the following matters:
(a) Matters regarding product management, and testing and inspections;
(b) Matters regarding an assessment of the results of testing and inspections and the handling of rejected products;
(c) Matters regarding management of testing and inspection facilities;
(d) Methods for contacting with the manufacturer of an imported medical device;
(e) Matters to check for the conditions of manufacture and quality management by a manufacturer of an imported medical device;
(f) The presenter and presentation date of import management standards (if revised, a person who revises, and the date and cause of revision shall be stated);
9. The importer shall check whether an imported medical device has the labeling and packaging in compliance and prepare the records thereon;
10. The importer shall inspect product storage facilities and prepare the records thereon;
11. The importer shall ensure that a quality manager implements the following matters:
(a) Where complaints against the quality of released medical devices are filed, the quality manager shall prepare and implement the relevant procedures to identify the causes thereof and take corrective measures, and shall prepare and retain such records;
(b) The quality manager shall keep and use a manual of product specifications and import management standards for proper quality management of imported medical devices;
(c) The quality manager shall prepare work instructions based on documents under item (b) and inspect and check whether they are properly operated in compliance with the standards;
12. The importer shall take corrective measures, such as recall without delay, where the safety and effectiveness of released medical devices are undermined or the quality thereof is poor;
13. The importer shall formulate education plans to enable his or her employees to ensure the quality of imported medical devices, hold regular education and training sessions based on the plans, and prepare and retain records thereon;
14. Where the importer is aware of new data or information on the safety and effectiveness of a medical device permitted, certified, or notified (including cases of side effects in relation to the use of the medical device), he or she shall report it and prepare necessary safety measures as determined by the Minister of Food and Drug Safety;
15. For a factory of imported medical devices, the importer shall import and distribute medical devices manufactured in compliance with the standards specified in subparagraph 3 of attached Table 4. In such cases, medical devices imported for the purpose of the recognition of compliance under subparagraph 3 of attached Table 4 and recognized as compliant under that subparagraph shall be deemed imported after being recognized as compliant under that subparagraph;
16. The importer shall comply with the guidelines for export and import of medical devices publicly announced by the Minister of Trade, Industry and Energy under Article 12 of the Foreign Trade Act and regulations for management of imported medical devices determined by the Minister of Food and Drug Safety;
17. The importer shall apply the latest standard specifications determined by the Minister of Food and Drug Safety pursuant to Article 19 of the Act to maintain facilities and manufacturing and quality management systems, to import medical devices, and to conduct quality management or import management;
18. The importer shall thoroughly perform the affairs of post-market safety management, including re-review, re-evaluation, management of medical devices subject to tracking management, and management of safety information (including management of reports on side effects);
19. Where the importer imports secondhand medical devices or purchases medical devices imported by his or her company from a medical institution, he or she shall observe the following:
(a) He or she shall inspect whether the medical devices are in compliance with the test specifications referred to in subparagraph 7 (c) and release them with certificates of inspection attached thereto only where they are in compliance with such specifications;
(b) He or she shall prepare and keep the records of the details and results of inspections under item (a), the date of issuing certificates of inspection, etc. and retain such records for two years from the date of release;
20. Where the importer is requested to conduct an inspection by a medical device distributor or lessor under subparagraph 1 (a) of Article 39, he or she shall observe the following:
(a) He or she shall inspect whether the medical devices are in compliance with the standards specified in subparagraph 2 of attached Table 2 and issue certificates of inspection only where they are in compliance with such standards;
(b) He or she shall comply with matters determined and publicly notified by the Minister of Food and Drug Safety regarding the procedures and methods for issuing certificates of inspection, period of reply, instructions on distribution or lease, etc.
(2) An importer shall report on the results of importing medical devices for the pertinent year to the Minister of Health and Welfare and the Minister of Food and Drug Safety as determined and publicly notified by the Minister of Food and Drug Safety under Article 13 (2) of the Act applied mutatis mutandis in accordance with Article 15 (6) of the Act: Provided, That such report need not be filed where a standard customs clearance forecast report has been filed in an electronic trade document under the Electronic Trade Facilitation Act.
 Article 34 (Application Mutatis Mutandis)
Articles 3 (3), 4, 5 (2) through (7), 6 (2) and (3), 7 (2) and (3), 9, 11 through 13, 16 through 19, 25, 26 (excluding Article 26 (1) 1), 28, and 64 shall apply mutatis mutandis to importers and import items. In such cases, "factory" shall be construed as "import business place", "manufacturing" as "import", "paragraph (1)" in Article 5 (4) as "Article 30 (1)", "Article 27 (1)” in Article 12 (1) 9 as “Article 33 (1)", "import" in Article 12 (3) 2 as "manufacturing", "Article 5 (1) 2" in Article 16 (2) as "Article 30 (1) 1", and "Article 5 (1) 2" in Article 16 (3) as "Article 30 (1) 1", respectively. <Amended by Ordinance of the Prime Minister No. 1307, Jul. 29, 2016; Ordinance of the Prime Minister No. 1389, May 1, 2017>
 Article 34-2 (Method for Supplying Orphan Medical Devices or Those in Urgent Need of Introduction)
(1) Where the Minister of Food and Drug Safety intends to supply orphan medical devices or those in urgent need of introduction under Article 15-2 (1), with the exception of its subparagraphs, of the Act (hereinafter referred to as "orphan medical devices or those in urgent need of introduction"), he or she shall conduct surveys on demand therefor from the relevant administrative agencies, medical institutions, health and medical services-related institutions, organizations and experts, patients, etc.
(2) Where the Minister of Food and Drug Safety conducts surveys on demand under paragraph (1), he or she shall establish quarterly, semi-annual, and annual plans to supply orphan medical devices or those in urgent need of introduction, including the following matters:
1. Matters regarding supply quantities;
2. Matters regarding supply prices;
3. Matters regarding supply targets;
4. Other matters deemed necessary by the Minister of Food and Drug Safety to supply orphan medical devices or those in urgent need of introduction.
(3) Where the Minister of Food and Drug Safety intends to supply orphan medical devices or those in urgent need of introduction in accordance with supply plans under paragraph (2), he or she shall conclude a supply contract with a supply target.
(4) Except as provided in paragraphs (1) through (3), details necessary for methods for supplying orphan medical devices or those in urgent need of introduction shall be determined and publicly notified by the Minister of Food and Drug Safety.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1542, Jun. 12, 2019]
 Article 34-3 (Entrustment of Supply of Orphan Medical Devices or Those in Urgent Need of Introduction)
(1) The Minister of Food and Drug Safety shall entrust the affairs related to the supply of orphan medical devices or those in urgent need of introduction and the provision of relevant information to the Information Institute under Article 15-2 (2) of the Act.
(2) The Information Institute entrusted with the affairs of orphan medical devices or those in urgent need of introduction under paragraph (1) shall submit to the Minister of Food and Drug Safety a business operation plan, a fund operation plan, an update on business progress, fund execution details, etc. regarding the entrusted affairs, as determined by the Minister of Food and Drug Safety.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1542, Jun. 12, 2019]
 Article 35 (Notification of Repair Business)
(1) A person who intends to engage in the business of repairing medical devices under Article 16 (1) of the Act shall submit a notification of repair business in attached Form 33 (including a notification in electronic form), along with the documents referred to in Article 3 (1) 1 and 2 (including electronic documents), to the Special Metropolitan City Mayor, a Metropolitan City Mayor, a Do Governor, or a Self-Governing Province Governor (hereinafter referred to as the "Mayor/Do Governor") having jurisdiction over the location of a repair business place. In such cases, the Mayor/Do Governor shall verify a corporation registration certificate (limited to a corporation) through administrative data matching under Article 36 (1) of the Electronic Government Act.
(2) Upon acceptance of a repair business notification pursuant to paragraph (1), the Mayor/Do Governor shall issue a certificate of notification in attached Form 34 to a person who files such notification, and enter the following information in the repair business notification register:
1. The notification acceptance number and acceptance date;
2. Types of medical devices to be repaired;
3. The name and resident registration number of the repairer (in cases of a corporation, the name and resident registration number of its representative);
4. The name and location of the repair business place (in cases of a corporation, the location of its principal office).
(3) Where a repairer intends to modify the notified matters, he or she shall submit a notification of modification in attached Form 35 (including a notification in electronic form) to the Mayor/Do Governor having jurisdiction over the location of the repair business place, along with reasons for such modification, evidentiary documents therefor (including electronic documents), and the certificate of notification. In such cases, where the change of a location changes the competent notification-receiving authority, he or she shall submit them to the Mayor/Do Governor having jurisdiction over the new location.
(4) Facilities and quality management systems to be secured by a person intending to file a notification of repair business under the main clause of Article 16 (2) of the Act shall be as specified in attached Table 5.
(5) Where a repairer closes or suspends his or her business under Article 14 of the Act applied mutatis mutandis in accordance with Article 16 (4) of the Act, he or she shall submit a notification in attached Form 32 (including a notification in electronic form), along with the certificate of notification, to the Mayor/Do Governor having jurisdiction over the location of the repair business place; and where a person who has suspended his or her business files a notification of business resumption, he or she shall submit a notification in attached Form 32 (including a notification in electronic form) to the Mayor/Do Governor having jurisdiction over the location of the repair business place.
(6) Upon receipt of a notification under paragraph (3) or (5), the Mayor/Do Governor shall enter the notification details in the relevant notification register and the certificate of notification, respectively.
(7) Article 28 (3) shall apply mutatis mutandis to a notification of business closure or business suspension under paragraph (5). In such cases, "the head of a regional office of food and drug safety" shall be construed as "the Mayor/Do Governor".
 Article 36 (Matters to Be Observed by Repairers)
Matters to be observed by repairers of medical devices under Article 13 of the Act applied mutatis mutandis in accordance with Article 16 (4) of the Act shall be as follows: <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
1. They shall not repair a medical device by altering inconsistently with the details permitted, certified, or notified: Provided, That this shall not apply to a minor repair for change under Article 46-2;
2. They shall state the trade name and address on the container or wrapper of a medical device, where such device is repaired;
3. They shall notify a person who requests the repair of a medical device of the repair details in writing (in cases of a minor repair for change under Article 46-2, the details of such repair for change shall be included);
4. They shall maintain facilities and quality management systems under Article 35 (4).
 Article 37 (Notification of Distribution Business or Leasing Business)
(1) A person who intends to engage in the business of distributing or leasing medical devices under Article 17 (1) of the Act shall submit a notification in attached Form 36 (including a notification in electronic form) to the Special Self-Governing Province Governor or the head of a Si/Gun/Gu (the head of a Gu refers to the head of an autonomous Gu; hereinafter the same shall apply) having jurisdiction over the distribution or leasing business place. In such cases, the Special Self-Governing Province Governor or the head of a Si/Gun/Gu shall verify a corporation registration certificate (limited to a corporation) through administrative data matching under Article 36 (1) of the Electronic Government Act.
(2) Upon acceptance of a notification of medical device distribution or leasing business under paragraph (1), the Special Self-Governing Province Governor or the head of a Si/Gun/Gu shall issue a certificate of notification in attached Form 37 and enter the following information in the distribution or leasing business notification register:
1. The notification number and notification date;
2. The name and resident registration number of the medical device distributor or lessor (in cases of a corporation, the name and resident registration number of its representative);
3. The name and location of the business place.
(3) Where a distributor or lessor modifies the matters notified pursuant to paragraph (1), he or she shall submit a notification of modification in attached Form 38 (including a notification in electronic form), along with the certificate of notification and documents verifying such modification, to the Special Self-Governing Province Governor or the head of a Si/Gun/Gu having jurisdiction over the distribution or leasing business place. In such cases, where the change of a location changes the competent notification-receiving authority, he or she shall submit them to the Mayor/Do Governor having jurisdiction over the new location.
(4) Where a distributor or lessor intends to file a notification of business closure or business suspension, he or she shall submit a notification in attached Form 32 (including a notification in electronic form), along with the certificate of notification, to the Special Self-Governing Province Governor or the head of a Si/Gun/Gu having jurisdiction over the distribution or leasing business place; and where a person who has suspended his or her business intends to file a notification of business resumption, he or she shall submit a notification in attached Form 32 (including a notification in electronic form) to the Special Self-Governing Province Governor or the head of a Si/Gun/Gu having jurisdiction over the distribution or leasing business place.
(5) Upon receipt of a notification under paragraph (3) or (4), the Special Self-Governing Province Governor or the head of a Si/Gun/Gu shall enter the notification details in the relevant notification register and the certificate of notification, respectively.
(6) Article 28 (3) shall apply mutatis mutandis to a notification of business suspension or business closure under paragraph (4). In such cases, "the head of a regional office of food and drug safety" shall be construed as "the Special Self-Governing Province Governor or the head of a Si/Gun/Gu".
 Article 38 (Exemption from Distribution Business Notification)
Any of the following medical devices may be distributed without filing a notification under Article 17 (2) 4 of the Act:
1. Condoms;
2. Mobile phones, household electric appliances, etc. which have a feature of blood glucose monitoring or blood glucose monitoring devices used in combination therewith;
3. Other medical devices publicly notified by the Minister of Food and Drug Safety in consideration of the degree of harm and safety.
 Article 39 (Method for Ensuring Quality of Medical Devices by Distributor or Lessor)
The method for ensuring the quality of medical devices under Article 18 (1) of the Act and subparagraph 1 of Article 10-2 of the Enforcement Decree of the Medical Devices Act (hereinafter referred to as the "Decree") shall be as follows: <Amended by Ordinance of the Prime Minister No. 1284, Jun. 15, 2016>
1. Where a distributor or lessor purchases medical devices from a medical institution, he or she shall comply with the following matters:
(a) The distributor or lessor shall request the manufacturer or importer of the relevant medical devices for inspections or request a medical device testing and inspection institution for inspections;
(b) The distributor or lessor shall distribute or lease only the medical devices that have received certificates of inspection issued pursuant to Article 27 (1) 15 (a) or 33 (1) 19 (a) according to the results of the inspections under item (a);
(c) Where the distributor or lessor receives any directions regarding distribution or lease pursuant to Article 27 (1) 16 (b) or 33 (1) 20 (b) according to the results of the inspections under item (a), he or she shall comply with such directions;
2. A distributor or lessor shall prepare the records of the details and results of an inspection under each item of subparagraph 1, the issuer and issuance date of a certificate of inspection, directions regarding distribution or lease, etc., and retain such records for two years from the date of distribution;
3. A distributor or lessor shall prepare and keep the records of the handling of defective medical devices and retain such records for one year from the date of record;
4. A distributor or lessor shall comply with the standards for distribution quality management of medical devices specified in attached Table 6: Provided, That this shall not apply where a distribution business notification is exempted under Article 17 (2) of the Act.
 Article 40 (Matters regarding Maintenance of Order in Distribution by Distributor or Lessor)
Matters regarding the maintenance of order in distribution in relation to the safety of medical devices and other matters under Article 18 (1) of the Act and subparagraph 1 of Article 10-2 of the Decree shall be as follows:
1. A distributor or lessor shall not purchase medical devices from persons other than manufacturers, importers, and distributors: Provided, That purchase from a medical institution shall be excluded;
2. A distributor or lessor shall not use any of the following names or labels for the name, etc. of a business place, or shall not use them together with the label of the business place:
(a) A name or label likely to be misunderstood as a business place of a manufacturer or an importer;
(b) The name of a medical institution under Article 3 of the Medical Service Act or any name similar thereto;
3. A distributor or lessor shall not distribute or lease any of the following medical devices, or shall not store or display them for the purpose of distribution or lease:
(a) Medical devices with no certificates of inspection attached under subparagraph 1 (b) of Article 39;
(b) Medical devices contaminated or damaged or those subject to an order of collection or destruction issued by the Minister of Food and Drug Safety or the head of a regional office of food and drug safety;
(c) Medical devices whose use-by dates or expiration dates have passed;
4. A distributor or lessor shall not distribute medical devices for which permission or certification has not been obtained or a notification has not been filed, or shall not store or display them for the purpose of distribution.
 Article 41 (Exemption from Certificates of Inspection of Secondhand Medical Devices)
Medical devices determined and publicly notified by the Minister of Food and Drug Safety, such as medical devices with low potential risk, may be distributed with no certificate of inspection attached, notwithstanding Articles 27 (1) 15 and 33 (1) 19, subparagraph 1 (b) of Article 39, and subparagraph 3 (a) of Article 40.
 Article 42 (Labeling on Container)
The container or wrapper of a medical device need not be labeled pursuant to the proviso of Article 20, with the exception of its subparagraphs, of the Act, in any of the following cases: <Amended by Ordinance of the Prime Minister No. 1284, Jun. 15, 2016>
1. Where the area of the container or wrapper is too small or the container or wrapper cannot contain all the matters referred to in the subparagraphs of Article 20 of the Act, and therefore, such matters are stated on an outside container, outside package, or package insert: Provided, That even in such cases, the model name or the trade name of a manufacturer or importer shall be stated on the container or wrapper of a medical device;
2. Where a medical device for export has been labeled in accordance with the standards of the export destination country.
 Article 43 (Labeling on Package Inserts)
(1) "Matters prescribed by Ordinance of the Prime Minister" in Article 22 (1) 4 of the Act means the following:
1. The matters prescribed in subparagraphs 1 through 3 and 5 through 7 of Article 20 of the Act;
2. The intended use of a product;
3. Keeping or storage methods;
4. The trade names and addresses of a person requesting manufacture (referring to an entrusting person) and a manufacturer (referring to an entrusted person), where a domestic manufacturer entrusts the entire manufacturing processes for manufacturing;
5. A model name and the name of a manufacturing business place labeled on a minimum unit package, in cases of individual packaging for single use;
6. Information regarding appropriate procedures for reuse, such as cleaning, disinfection, packaging, re-sterilization methods, and the limit on the number of times of reuse, in cases of medical devices reusable after sterilization;
7. Matters regarding characteristics, types, intensity, diffusion, etc. of radiation, in cases of medical devices emitting radiation for the purpose of medical treatment;
8. The date of preparing package inserts;
9. Other matters regarding technical information such as characteristics of medical devices.
(2) The following shall be stated in the package insert of a medical device for clinical trials, notwithstanding paragraph (1):
1. The label "For Clinical Trials";
2. The product name and model name;
3. The manufacturing number and manufacturing date (which may be replaced with the use-by date, if any);
4. Keeping (storage) methods;
5. The trade name of a manufacturer or an importer (in cases of entrusted manufacturing or import, including the origin of manufacture and country name);
6. The label "Not Permitted for Use for Purposes Other than Clinical Trials".
(3) Where the matters prescribed in paragraph (1) 1 through 5 are stated on a container, wrapper, or package, the package insert may not include such labeling.
 Article 44 (Labeling Methods)
(1) Pursuant to Article 23 of the Act, the container, wrapper, outside container, package, or package insert of a medical device shall be labeled according to the following methods:
1. The Korean alphabet Hangeul shall be used, or Chinese characters or foreign languages with the same letter size with Hangeul shall be used with Hangeul: Provided, That only the language of an export destination country shall be used for medical devices for export;
2. Letter size, line height, and other labeling methods determined and publicly notified by the Minister of Food and Drug Safety shall be followed.
(2) Where the name of a product, the trade name of a manufacturer or importer, or other matters are stated on the container, outer package, or package of a medical device, braille may be used in conjunction with the labeling methods under paragraph (1).
 Article 45 (Scope of Medical Device Advertisements)
(1) The scope of advertisements prohibited under Article 24 (2) and (3) of the Act shall be any of the following advertisements specified in attached Table 7: <Amended by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
1. Advertisements under subparagraph 2 of Article 2 of the Act on Fair Labeling and Advertising;
2. Advertisements through methods such as solicitation of purchase and product presentation and demonstration by a medical device handler (including workers, etc. employed by the medical device handler).
(2) "Organization determined by Ordinance of the Prime Minister" in Article 25 (2) of the Act means a corporation designated and publicly notified by the Minister of Food and Drug Safety among medical device-related corporations which have obtained incorporation permission from the Minister of Food and Drug Safety under Article 32 of the Civil Act.
 Article 46 (Approval for Display of Medical Devices for Purpose of Exhibition)
(1) A person who intends to display medical devices for the purpose of exhibition under the proviso of Article 26 (1) of the Act shall obtain approval therefor from the head of a regional office of food and drug safety in advance.
(2) A person who intends to display medical devices approved under paragraph (1) shall not engage in acts other than those determined and publicly notified by the Minister of Food and Drug Safety, such as the simple operation of devices to explain the methods for use, etc. and attachment or keeping of promotional materials regarding the notified details.
(3) Where medical devices approved under paragraph (1) fall under any of the following cases, the head of a regional office of food and drug safety shall cancel such approval, and may take measures including the enveloping or sealing of the relevant medical devices or the suspension of the display thereof:
1. Where medical devices are displayed or used differently from what have been approved;
2. Where acts, other than those permitted under paragraph (2), are performed;
3. Where other acts likely to cause harm to public health are performed.
(4) Details regarding methods and procedures for filing an application for approval under paragraph (1), approval standards, and other matters shall be determined and publicly notified by the Minister of Food and Drug Safety.
 Article 46-2 (Minor Repair for Change of Medical Devices)
A medical device repairer may make repairs to change any of the following external appearances within the extent not to affect the safety and effectiveness of the medical devices under the proviso of Article 26 (3) of the Act:
1. Repairs to change the colors, materials, etc. of outer packages aimed at protecting medical devices from external shock;
2. Repairs to change the shapes, structures, etc. of external appearances, such as holders, handles, or wheels, not directly related to the performance of medical devices.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018]
 Article 47 (Scope of Permission to Alter or Remodel Medical Devices)
Medical devices that manufacturers and importers may alter or remodel under Article 26 (4) 1 of the Act shall be as follows. In such cases, such medical devices shall be altered or remodeled within the extent not to change the unique characteristics but to improve the performance thereof:
1. Radiation-generating devices for diagnosis under Article 37 of the Medical Service Act;
2. Special medical equipment under Article 38 of the Medical Service Act;
3. Other medical devices determined and publicly notified by the Minister of Food and Drug Safety, whose safety and effectiveness are not affected by alteration or remodeling.
 Article 48 (Designation of Quality Management Review Institution)
(1) A person who intends to be designated as a quality management review institution under Article 28 (2) of the Act shall submit an application for designation as a medical device quality management review institution in attached Form 39 (including an application in electronic form) to the Minister of Food and Drug Safety, along with the following documents (including electronic documents):
1. The current status of a quality management review institution in terms of its organization and personnel (referring to documents evidencing the personnel's qualifications and work experience);
2. Documents regarding management and operational standards for quality review affairs;
3. Documents regarding the scope of quality review affairs.
(2) Where a quality management review institution is designated based on the results of the examination of documents submitted under paragraph (1) and the fact-finding surveys on quality review capabilities, the Minister of Food and Drug Safety shall issue a certificate of designation as a medical device quality management review institution in attached Form 40.
(3) In cases of modification of any of the following matters, a quality management review institution designated under paragraph (2) shall submit an application for modification of designated matters of a medical device quality management review institution in attached Form 41 (including an application in electronic form), along with the certificate of designation as a medical device quality management review institution and data verifying the modified matters (including electronic documents), to the Minister of Food and Drug Safety, within 30 days from the date reasons for such modification occur:
1. The representative of the quality management review institution;
2. The name and location of the quality management review institution;
3. The scope of quality review affairs.
(4) Matters to be observed by a quality management review institution under Article 28 (4) of the Act shall be as follows:
1. The institution shall retain for five years the records on quality review, such as copies of compliance certificates and all review data regarding issuance of compliance certificates;
2. The institution shall report on the results of quality review as determined by the Minister of Food and Drug Safety;
3. The institution shall comply with the management and operational standards for medical device quality management review institutions, which are determined and publicly notified by the Minister of Food and Drug Safety;
4. The institution shall maintain the requirements for designation as a quality management review institution under Article 28 (3) of the Act;
5. The institution shall comply with other matters determined and publicly notified by the Minister of Food and Drug Safety, such as matters to be stated by a quality management review institution when issuing compliance certificates.
(5) The Minister of Food and Drug Safety may conduct a regular or occasional investigation into a quality management review institution.
(6) Except as provided in paragraphs (1) through (5), details necessary for procedures and methods for designating a quality management review institution, operation thereof, etc. shall be determined and publicly notified by the Minister of Food and Drug Safety.
 Article 49 (Standards for Designation and Management of Medical Devices Subject to Tracking Management)
(1) Medical devices subject to tracking management under the subparagraphs of Article 29 (1) of the Act shall be as follows:
1. The following medical devices to be inserted into the human body for at least one year:
(a) Implantable cardiac pacemakers;
(b) Implantable cardiac pacemaker electrodes;
(c) Composite artificial heart valves;
(d) Biological artificial heart valves;
(e) Non-biological artificial heart valves;
(f) Implantable cardioverter-defibrillators (ICDs);
(g) Electrically-powered implantable infusion pumps;
(h) Other medical devices determined and publicly notified by the Minister of Food and Drug Safety as necessary to track the locations of such devices;
2. The following medical devices for life support used in any place other than a medical institution:
(a) Home care ventilators (limited to regular wearing);
(b) Other medical devices determined and publicly notified by the Minister of Food and Drug Safety as necessary to track the locations of such devices.
(2) Where the Minister of Food and Drug Safety permits the manufacture, import, etc. of medical devices subject to tracking management under paragraph (1), he or she shall state in the permit the phrase "Medical Device Subject to Tracking Management".
 Article 50 (Matters regarding Records on Medical Devices Subject to Tracking Management)
(1) Manufacturers, importers, distributors, lessors, and repairers who handle medical devices under Article 30 (1) of the Act (hereinafter referred to as "handlers") and the founders of medical institutions that handle medical devices subject to tracking management, and medical doctors, oriental medical doctors, dentists, etc. who work at medical institutions (hereinafter referred to as "users") shall prepare records of the following matters:
1. Records of handlers:
(a) The quantity and date of manufacture or import (limited to manufacturers or importers) by product name (by item name, in the absence of the product name), by model name, and by manufacture unit;
(b) The quantity and date of distribution or lease; the trade name and address of a distributor or lessor or the founder of a medical institution (excluding repairers) by product name (by item name, in the absence of the product name), by model name, and by manufacture unit;
(c) The date of repair and the trade name and address of a requester (limited to repairers) by product name (by item name, in the absence of the product name), by model name, and by manufacture unit;
(d) Other matters necessary to prevent harm to health and hygiene;
2. Records of users:
(a) The name, address, birth date, and gender of a patient who uses a medical device subject to tracking management;
(b) The name and manufacturing number of a medical device subject to tracking management, and those in lieu thereof;
(c) The date of use of a medical device subject to tracking management;
(d) The name and location of a medical institution that uses a medical device subject to tracking management;
(e) Other matters necessary to prevent harm to health and hygiene.
(2) Handlers or users of medical devices subject to tracking management shall submit records and data related to the medical devices subject to tracking management to the Minister of Food and Drug Safety according to the following classifications. In such cases, such handlers or users may submit such records and data using a computer program determined by the Minister of Food and Drug Safety: <Newly Inserted by Ordinance of the Prime Minister No. 1284, Jun. 15, 2016>
1. Handlers: Handlers shall prepare records and data related to medical devices subject to tracking management every month and submit such records and data by the end of the following month as determined and publicly notified by the Minister of Food and Drug Safety;
2. Users: Upon receipt of a request by the Minister of Food and Drug Safety to submit records and data related to medical devices subject to tracking management, users shall submit such records and data within 10 days from the date of receipt of such request.
(3) Where handlers and users of medical devices subject to tracking management prepare records under paragraph (1), they shall maintain confidentiality.
(4) Records of medical devices subject to tracking management under paragraph (1) shall be retained until the time determined by the following subparagraphs:
1. Where a medical device subject to tracking management is no longer used due to the death, etc. of a patient who has used such medical device;
2. Where the reasons to retain the previous records of a non-single-use medical device subject to tracking management cease to exist as the information thereon under paragraph (1) 2 (a) or (c) is newly recorded;
3. Where the reasons to retain the relevant records cease to exist, as tracking management is no longer necessary or any other reason occurs.
(5) The Minister of Food and Drug Safety may create and operate unique device identification (UDI) codes to be attached or labeled on the containers, outer packages, or packages of medical devices subject to tracking management for an efficient management of medical devices subject to tracking management.
 Article 51 (Reporting on Side Effects)
(1) A person who intends to file a report on the side effects of a medical device under Article 31 (1) of the Act shall do so as prescribed in the following subparagraphs and retain the relevant data for two years:
1. Within seven days, where a medical device causes death or life-threatening side effects. In such cases, the details thereof shall be additionally reported within eight days from the date of the first report;
2. Within 15 days, where the following side effects are caused or adverse events occur:
(a) Where admission to a hospital or the extension of an admission period is required;
(b) Where recovery is impossible or a serious disability or impaired function is caused;
(c) Where congenital malformations or abnormalities are caused.
(2) The Minister of Food and Drug Safety shall notify the founder of a medical institution of side effects, a recall plan, etc. under Article 31 (4) of the Act by means of visit, mail, telephone, e-mail, fax, etc.
(3) The founder of a medical institution who has notified patients of the side effects, recall plan, etc. under Article 31 (5) of the Act shall prepare a written confirmation of notice to the patients in attached Form 42 and submit it to the Minister of Food and Drug Safety. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(4) Except as provided in paragraphs (1) through (3), details regarding the reporting and management of side effects shall be determined and publicly notified by the Minister of Food and Drug Safety.
 Article 52 (Standards and Procedures for Recall of Harmful Medical Devices)
(1) With respect to any medical device that has caused, or is likely to cause, harm to the human body among the medical devices repaired, distributed, or leased (hereinafter referred to as "medical device subject to recall"), the relevant medical device repairer, distributer, or lessor shall immediately cease repairing, distributing, or leasing such medical device pursuant to Article 31 (2) of the Act, and notify such fact to the manufacturer or importer of such medical device (hereinafter referred to as "person responsible for recall").
(2) Pursuant to Article 31 (2) of the Act, with respect to medical devices that a person responsible for recall has distributed or leased after manufacturing or importing such devices, such person responsible for recall shall verify whether any medical device suspected to be subject to recall or any medical device notified under paragraph (1) falls under any of the following:
1. A medical device, the use of which causes serious irreversible side effects or death, or a medical device that is likely to cause such side effects or death;
2. A medical device, the use of which causes reversible temporary or medical side effects, or a medical device that is likely to cause such side effects;
3. A medical device which, when used, rarely causes side effects, but is problematic in terms of safety and effectiveness for failing to satisfy the standard specifications referred to in Article 19 of the Act.
(3) With respect to any medical device found to be falling under any subparagraph of paragraph (2) based on the results of verification under paragraph (2), a person responsible for recall shall take measures, such as immediately ceasing the distribution of the relevant medical device, and submit a recall plan in attached Form 43 (including a plan in electronic form) to the head of a regional office of food and drug safety having jurisdiction over the location of the person responsible for recall within five days from the date of verification under paragraph (2). In such cases, the person responsible for recall may submit a recall plan using a computer program determined by the Minister of Food and Drug Safety: <Amended by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018; Ordinance of the Prime Minister No. 1580, Dec. 23, 2019>
1. and 2. Deleted. <by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
(4) Notwithstanding paragraph (3), with respect to any medical device falling under paragraph (2) 3, where a person responsible for recall finds it impracticable to submit a recall plan within five days, he or she may request the head of a regional office of food and drug safety to extend the submission period by up to 10 days only once, specifying the reasons for such request. <Newly Inserted by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
(5) Where a person responsible for recall submits a recall plan under paragraph (3), he or she shall attach the following documents thereto (including documents in electronic form): <Amended by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018; Amended by Ordinance of the Prime Minister No. 1542, Jun. 12, 2019; Ordinance of the Prime Minister No. 1580, Dec. 23, 2019>
1. A copy of the records on the manufacturing or import of the relevant item, the records on the distribution amount and date by distributor, the records on the lease amount and date by lessor, etc.;
2. A notice of a recall plan to be notified under Article 53 (3);
3. Deleted; <by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
4. Where a medical device subject to recall falls under paragraph (2) 1, the name and location of a medical institution that has used the relevant medical device and information on its founder including his or her name.
(6) Where a person responsible for recall prepares a recall plan under paragraph (3), he or she shall determine the scheduled date for completion of the recall according to the following classifications: Provided, That where it is deemed impracticable to make the recall within such date, the period of recall may be determined in excess of the period classified as follows, stating the reasons therefor: <Amended by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
1. A medical device falling under paragraph (2) 1: Within 15 days from the start date of the recall;
2. A medical device falling under paragraph (2) 2 or 3: Within 30 days from the start date of the recall.
(7) Where any recall plan submitted under paragraphs (3) through (5) is deemed insufficient, the head of a regional office of food and drug safety may order the relevant person responsible for recall to supplement such recall plan. <Amended by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
(8) Except as provided in paragraphs (1) through (7), details regarding the evaluation of the degree of harm of medical devices, the preparation and supplement of recall plans, etc. shall be determined and publicly notified by the Minister of Food and Drug Safety. <Newly Inserted by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
 Article 53 (Publication of Recall Plans)
(1) Upon receipt of an order to publish a recall plan from the head of a regional office of food and drug safety pursuant to Article 31 (3) of the Act, a person responsible for recall shall publish such recall plan according to the following classifications:
1. Medical devices falling under Article 52 (2) 1: Public announcement of the recall plan through broadcasting defined in subparagraph 1 of Article 2 of the Broadcasting Act; daily newspapers (referring to all the copies of the relevant newspapers printed and distributed for a day) which are distributed nationwide and registered under Article 9 (1) of the Act on the Promotion of Newspapers, Etc.; or mass media at least equivalent thereto (including such media as may be recognized by the Minister of Food and Drug Safety in consideration of the intended uses, methods for use, etc. of medical devices subject to recall);
2. Medical devices falling under Article 52 (2) 2: Public announcement of the recall plan in medical journals or medical engineering journals or media at least equivalent thereto;
3. Medical devices falling under Article 52 (2) 3: Public announcement of the recall plan on the website of a person responsible for recall or media at least equivalent thereto.
(2) The head of a regional office of food and drug safety may post the trade name of a person responsible for recall; the name, manufacturing number, date of manufacturing, use-by date, and expiration date of a product; and the reason for recall on the website of the regional office of food and drug safety.
(3) A person responsible for recall shall notify a recall plan to a repairer, distributer, lessor, or founder of a medical institution that handles medical devices subject to recall (hereinafter referred to as "handler of medical devices subject to recall") via visit, mail, telephone, telegram, e-mail, fax, public announcement through media, etc., and retain data evidencing such notice for two years from the date of completion of recall.
(4) A handler of medical devices subject to recall notified of a recall plan under paragraph (3) shall take measures, such as returning a medical device subject to recall, and prepare a written confirmation of recall in attached Form 44 and send it to the person responsible for the recall of such medical device subject to recall.
(5) Deleted. <by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(6) The Minister of Food and Drug Safety may establish and operate a computer program that provides information on medical devices subject to recall, etc., and recommend that a handler of medical devices subject to recall, etc. install such program.
(7) Except as provided in paragraphs (1) through (6), details regarding the method and period for publication of recall plans, notice of such plans, etc. shall be determined and publicly notified by the Minister of Food and Drug Safety. <Newly Inserted by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
[Paragraph (5) of this Article shall be effective until May 10, 2016 pursuant to Article 2 of the Addenda to the Ordinance of the Prime Minister No. 1181 promulgated on July 29, 2015.]
 Article 54 (Destruction of Medical Devices Subject to Recall)
(1) A person responsible for recall shall destroy a medical device that has been recalled or returned or take other measures to prevent harm, and prepare a recall evaluation report in attached Form 45 (including a report in electronic form) with respect thereto. <Amended by Ordinance of the Prime Minister No. 1580, Dec. 23, 2019>
(2) Where a person responsible for recall destroys a medical device subject to recall pursuant to paragraph (1), he or she shall submit an application for destruction in attached Form 46 (including an application in electronic form), along with the following documents (including documents in electronic form), to the competent Mayor/Do Governor; destroy the relevant medical device in accordance with the environment-related statutes and regulations in the presence of the relevant public officials of the competent Special Metropolitan City, Metropolitan City, Do, and Special Self-Governing Province (hereinafter referred to as "City/Do"); and prepare a written confirmation of destruction in attached Form 47 (including a written confirmation in electronic form) and retain it for two years: <Amended by Ordinance of the Prime Minister No. 1580, Dec. 23, 2019>
1. A copy of a recall plan in attached Form 43;
2. A copy of a written confirmation of recall in attached Form 44.
(3) Upon completion of a recall, a person responsible for recall shall submit a recall completion report in attached Form 48 (including a report in electronic form), along with the following documents (including documents in electronic form), to the head of a regional office of food and drug safety having jurisdiction over the location of the person responsible for recall. In such cases, the person responsible for recall may submit the relevant recall completion report using a computer program determined by the Minister of Food and Drug Safety: <Amended by Ordinance of the Prime Minister No. 1580, Dec. 23, 2019>
1. A copy of a written confirmation of recall in attached Form 44;
2. A copy of a recall evaluation report in attached Form 45;
3. A copy of a written confirmation of destruction in attached Form 47 (limited to where a medical device has been destroyed).
(4) Upon receipt of a recall completion report under paragraph (3), the head of a regional office of food and drug safety shall take measures according to the following classifications:
1. Where it is deemed that the recall of a medical device subject to recall has been properly conducted according to the recall plan, the completion of the recall shall be confirmed and notified in writing to the person responsible for recall;
2. Where it is deemed that the recall has not been effectively conducted, the person responsible for recall shall be ordered to take additional measures necessary for the recall.
(5) Where the destruction under paragraph (2) is completed, the Mayor/Do Governor shall notify such fact to the head of a regional office of food and drug safety having jurisdiction over the location of the person responsible for recall.
(6) Except as provided in paragraphs (1) through (5), details regarding measures such as destruction, preparation of recall evaluation reports, reporting on completion of a recall, measures to be taken, etc. shall be determined and publicly notified by the Minister of Food and Drug Safety. <Newly Inserted by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
 Article 54-2 (Reporting on Details of Supply of Medical Devices)
A person who intends to report the details of the supply of medical devices pursuant to Article 31-2 (1) of the Act shall submit a report on the details of the supply of medical devices in attached Form 48-2 (including electronic documents) to the Minister of Food and Drug Safety, using an integrated medical device information system pursuant to Article 31-3 (1) of the Act (hereinafter referred to as “integrated medical device information system”), by the end of the month following the month when the relevant medical devices are supplied.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1567, Oct. 22, 2019]
<<Enforcement Date>> The amended provisions of Article 54-2 shall enter into force on the date according to the following classifications:
1. Class IV medical devices: July 1, 2020;
2. Class III medical devices: July 1, 2021;
3. Class II medical devices: July 1, 2022;
4. Class I medical devices: July 1, 2023.
 Article 54-3 (Operation of Integrated Medical Device Information System)
(1) The information to be registered (including registration of modifications; hereinafter the same shall apply) by medical device manufacturers and importers in the integrated medical device information system pursuant to Article 31-3 (2) of the Act (hereinafter referred to as "medical device information, etc.") shall be as follows:
1. Information on UDI codes of medical devices;
2. Information on medical device products (including information on medical device permission, certification, or notification);
3. Information on medical device manufacturers and importers (including the foreign origins of manufacture).
(2) The standards to be observed by medical device manufacturers and importers in registering and managing medical device information, etc. pursuant to Article 31-3 (3) of the Act (hereinafter referred to as "standards for management of integrated medical device information") shall be as specified in attached Table 7-2.
(3) The Minister of Food and Drug Safety may require the head of the integrated medical device information center to conduct the following affairs:
1. Educating medical device manufacturers and importers regarding the registration of medical device information, etc. and the methods for using the integrated medical device information system, etc.;
2. Providing information on the permission, certification, and notification of medical devices, precautions for the use of medical devices, etc.
(4) Details necessary for the operation and management of the integrated medical device information system, including the target and scope of medical device information, etc. under paragraph (1) and the methods for providing medical device information, etc., shall be determined and publicly notified by the Minister of Food and Drug Safety.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018]
<<Enforcement Date>> Article 54-3 shall enter into force on the date specified as follows:
(a) For Class IV medical devices: July 1, 2019;
(b) For Class III medical devices: July 1, 2020;
(c) For Class II medical devices: July 1, 2021;
(d) For Class I medical devices: July 1, 2022.
 Article 54-4 (Standards, Targets, and Procedures for Reporting Foreign Substances)
(1) The scope of foreign substances to be reported to the Minister of Food and Drug Safety by a medical device handler pursuant to Article 31-5 (1) of the Act (hereinafter referred to as "foreign substances") shall be as follows:
1. A substance that is not a normal material used for medical devices, such as metal, plastic, or debris generated during manufacturing processes and that may cause direct or indirect harm or damage to the human body during the use of medical devices;
2. A substance related to living things such as insects and their eggs, parasites and their eggs, and animal carcasses that may cause direct or indirect harm or damage to the human body during the use of medical devices;
3. Other substances determined and publicly notified by the Minister of Food and Drug Safety to prevent harm caused by the use of medical devices among the substances equivalent to those falling under subparagraph 1 or 2.
(2) Medical device handlers who intend to report the discovery of foreign substances pursuant to Article 31-5 (1) of the Act shall submit a foreign substance discovery report in attached Form 48-3 (including a report in electronic form), along with evidentiary data, to the Minister of Food and Drug Safety. <Amended by Ordinance of the Prime Minister No. 1567, Oct. 22, 2019>
(3) Upon receipt of a report on the discovery of foreign substances pursuant to paragraph (2), the Minister of Food and Drug Safety shall notify the details thereof to the head of a regional office of food and drug safety without delay.
(4) Upon receipt of notice under paragraph (3), the head of a regional office of food and drug safety shall conduct an investigation into the cause of inclusion of the foreign substances without delay pursuant to Article 31-5 (2) of the Act. In such cases, the head of a regional office of food and drug safety may request necessary cooperation from the relevant central administrative agencies, local governments, public institutions, corporations, organizations, experts, etc. to investigate the cause of inclusion of the foreign substances.
(5) Upon completion of an investigation into the cause of inclusion of foreign substances pursuant to paragraph (4), the head of a regional office of food and drug safety shall take the following measures without delay in comprehensive consideration of the results of the relevant investigation, the stability of medical devices, the need to prevent harm, etc.:
1. An order to conduct an inspection pursuant to Article 33 of the Act;
2. An order of recall, destruction, or any other treatment or the publication thereof pursuant to Article 34 of the Act;
3. An order of necessary measures such as suspension of use or repair pursuant to Article 35 of the Act.
(6) Except as provided in paragraphs (1) through (5), details necessary for the procedures and methods for reporting the discovery of foreign substances and for an investigation into inclusion of foreign substances, and relevant measures shall be determined and publicly notified by the Minister of Food and Drug Safety.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1542, Jun. 12, 2019]
 Article 55 (Collection)
(1) Where collecting medical devices pursuant to Article 32 (1) 2 of the Act, a certificate of collection in attached Form 49 shall be issued to a person subject to collection.
(2) Where a specialized inspection of any medical device collected under paragraph (1) is required, a request for a specialized inspection may be made to a medical device testing and inspection institution or an institution conducting non-clinical studies. <Amended by Ordinance of the Prime Minister No. 1389, May 1, 2017>
 Article 56 (Medical Device Surveillance Officer Identification)
An identification proving the identity of a relevant public official under Article 32 (2) of the Act (including cases applicable mutatis mutandis under the latter part of Article 34 (2) of the Act) shall be as prepared in attached Form 50.
 Article 56-2 (Procedures for On-Site Inspections and Suspension of Import)
(1) Where the Minister of Food and Drug Safety intends to conduct an on-site inspection pursuant to Article 32-2 (1), with the exception of its subparagraphs, of the Act (hereinafter referred to as "on-site inspection"), he or she shall notify the details of the on-site inspection in writing (including electronic documents) to the medical device manufacturer, the medical device importer, the manager of an overseas factory, or the government of an exporting country 20 days prior to conducting the on-site inspection.
(2) Upon completion of an on-site inspection under Article 32-2 (2) of the Act (including where an on-site inspection is refused), the Minister of Food and Drug Safety shall notify the results of the inspection and provide opinions on the necessary measures to the head of a regional office of food and drug safety within 30 days from the completion date of the on-site inspection.
(3) The head of a regional office of food and drug safety notified of the results of an on-site inspection under paragraph (2) may take the following measures pursuant to Article 32-2 (2) of the Act. In such cases, with respect to the relevant measure taken, the head of a regional office of food and drug safety shall notify the matters pertaining the details of, reasons for, and date of such measure, etc. in writing (including electronic documents) to the medical device manufacturer, the medical device importer, the manager of an overseas factory, or the government of an exporting country:
1. Suspension of import;
2. An order of recall, destruction, or any other measure or the publication thereof pursuant to Article 34 of the Act;
3. An order of necessary measures, such as suspension of use or repair, under Article 35 of the Act.
(4) Where any measure is canceled pursuant to Article 32-2 (3) of the Act, such as suspension of import, the head of a regional office of food and drug safety shall notify the matters pertaining the details of, reasons for, and date of the cancellation, etc. in writing (including electronic documents) to the medical device manufacturer, the medical device importer, the manager of an overseas factory, or the government of an exporting country.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1542, Jun. 12, 2019]
 Article 57 (Orders of Recall, Destruction, and Publication)
(1) Pursuant to Article 34 (3) of the Act, upon verification as to whether a medical device under the subparagraphs of Article 34 (1) of the Act falls under any subparagraph of Article 52 (2), the head of a regional office of food and drug safety, the Special Self-Governing Province Governor, or the head of a Si/Gun/Gu may order a person responsible for recall to recall or destroy the relevant medical device or to perform other treatments, and to publish such fact. <Amended by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
(2) Articles 52 (3) through (8), 53, and 54 shall apply mutatis mutandis to the methods for recall, destruction, or publication under paragraph (1). <Amended by Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
 Article 58 (Standards for Administrative Dispositions)
(1) The standards for administrative dispositions under Article 36 of the Act shall be as specified in attached Table 8.
(2) The standards for administrative dispositions under Article 37 of the Act shall be as specified in attached Table 9.
 Article 59 (Qualifications and Scope of Duties of Medical Device Surveillance Officers)
(1) Medical device surveillance officers under Article 40 of the Act shall be appointed by the Minister of Health and Welfare, the Minister of Food and Drug Safety, the head of a regional office of food and drug safety, the Mayor/Do Governor, or the head of a Si/Gun/Gu from among any of the following public officials under the authority thereof:
1. A person who has graduated from a junior college or a university or college, majoring in medicine, pharmacy, dentistry, oriental medicine, veterinary medicine, medical engineering, or natural science or engineering or a person who has qualifications at least equivalent thereto;
2. A person who has work experience in health care administration for at least one year.
(2) The scope of duties of medical device surveillance officers shall be as follows: <Amended by Ordinance of the Prime Minister No. 1389, May 1, 2017; Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
1. In cases of medical device surveillance officers belonging to the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, or a regional office of food and drug safety, the following duties: Provided, That where it is necessary to conduct a national survey, systematic survey, etc., the duties referred to in subaparagraphs 2 and 3 may be performed:
(a) Follow-up surveillance of medical device manufacturers and importers and collection and inspection of medical devices;
(b) Follow-up surveillance of institutions reviewing technical documents, clinical trial institutions, institutions conducting non-clinical studies, quality management review institutions, and other places handling medical devices in the process of conducting business affairs; and collection and inspection of medical devices (limited to medical device surveillance officers belonging to the Ministry of Food and Drug Safety or a regional office of food and drug safety);
2. In cases of medical device surveillance officers belonging to a City/Do, follow-up surveillance of medical device repairers;
3. In cases of medical device surveillance officers belonging to a Si/Gun/Gu, follow-up surveillance of medical device distributors and lessors, the founders of medical institutions under the Medical Service Act, and the founders of veterinary hospitals under the Veterinarians Act.
 Article 59-2 (Qualifications of Customer Medical Device Surveillance Officers)
(1) The head of a regional office of food and drug safety, the Special Metropolitan City Mayor, a Metropolitan City Mayor, a Do Governor, the Special Self-Governing Province Governor, the Special Self-Governing City Mayor, or the head of a Si/Gun/Gu may commission any of the following persons as a consumer medical device surveillance officer pursuant to Article 40-2 (1) of the Act:
1. A person falling under any subparagraph of Article 59 (1);
2. A person with work experience at a company or institution related to medical devices for at least one year;
3. A person who has completed an education program determined and publicly notified by the Minister of Food and Drug Safety;
4. From among the members or employees of associations or organizations related to medical devices, a person recommended by the head of the relevant association or organization;
5. From among the executive officers and employees of consumer organizations registered under Article 29 of the Framework Act on Consumers, a person recommended by the head of the relevant organization.
(2) A consumer medical device surveillance officer commissioned under paragraph (1) (hereinafter referred to as "consumer medical device surveillance officer") shall serve for two years and may be re-commissioned for another term of two years.
(3) "Matters prescribed by Ordinance of the Prime Minister" in Article 40-2 (2) 3 of the Act shall be as follows:
1. Assisting relevant public officials in destroying, enveloping, or sealing goods pursuant to Article 34 (2) of the Act;
2. Reporting and providing information on violators of statutes and regulations related to medical devices;
3. Others affairs such as public campaigns for the safe management of medical devices.
(4) Upon commission of a consumer medical device surveillance officer under paragraph (1), the head of a regional office of food and drug safety, the Special Metropolitan City Mayor, a Metropolitan City Mayor, a Do Governor, the Special Self-Governing Province Governor, the Special Self-Governing City Mayor, or the head of a Si/Gun/Gu shall provide education on the statutes and regulations, etc. related to medical devices at least once a year to such commissioned consumer medical device surveillance officer pursuant to Article 40-2 (4) of the Act.
(5) A written approval for unaccompanied access to a distribution or leasing business place by a consumer medical device surveillance officer and an identification indicating his or her status under Article 40-2 (7) of the Act shall be as prepared in attached Forms 50-2 and 50-3, respectively.
(6) Except as provided in paragraphs (1) through (5), details regarding the operation of consumer medical device surveillance officers shall be determined and publicly notified by the Minister of Food and Drug Safety.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1284, Jun. 15, 2016]
 Article 60 (Procedures and Methods for Revoking Certification or Notification)
The procedures, methods, etc. for revocation under Article 43-2 of the Act shall be governed by the Administrative Procedures Act.
 Article 61 (Guidance and Supervision for the Information Institute)
The Minister of Food and Drug Safety shall provide guidance and supervision on the following matters to the Information Institute at least once a year pursuant to Article 43-3 (4) of the Act: <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
1. Whether the affairs related to certification or notification entrusted to the Information Institute pursuant to Article 44 (2) of the Act have been appropriately performed;
2. Whether the operational budget has been appropriately compiled and executed;
3. Other matters deemed necessary by the Minister of Food and Drug Safety.
 Article 61-2 (Qualifications, Scope of Duties, and Identifications of Investigators of Causal Relationship)
(1) An investigator of causal relationship under Article 43-5 (1) of the Act (hereinafter referred to as "investigator of causal relationship") shall be appointed or commissioned from among any of the following persons:
1. An employee of the Information Institute responsible for investigating and identifying the causal relationship between medical devices and the side effects;
2. A public health doctor defined in Article 2 of the Act on Special Measures for Health and Medical Services in Agricultural and Fishing Villages, Etc.;
3. A medical doctor, dentist, oriental medical doctor, or nurse referred to in Article 2 (1) of the Medical Service Act;
4. Other persons with abundant expertise and experience in fields related to medical devices.
(2) The head of the Information Institute may pay allowances and travel expenses to a commissioned investigator of causal relationship within the budget.
(3) An investigator of causal relationship may investigate and identify the causal relationship between medical devices and the side effects in any of the following cases:
1. Where side effects falling under Article 51 (1) 1 or 2 have occurred or are suspected to have occurred during the use of medical devices;
2. Where unintended syndromes, symptoms, or diseases have occurred in large numbers to patients who have used the medical devices at a specific region or time;
3. Other cases where the Minister of Food and Drug Safety deems it necessary to investigate and identify the causal relationship between medical devices and the side effects.
(4) An identification indicating the authority of an investigator of causal relationship referred to in the latter part of Article 43-5 (3) of the Act shall be as prepared in attached Form 50-4.
(5) "Relevant documents" in the latter part of Article 43-5 (3) of the Act means documents including the following matters:
1. The purpose, duration, scope, and contents of the investigation;
2. The name and position of a person responsible for the investigation;
3. The list of submitted data;
4. The statutes and regulations serving as a legal basis for the investigation;
5. The details of administrative dispositions, penalties, etc. for the refusal, obstruction, evasion, etc. of the investigation and statutes and regulations used as a legal basis therefor;
6. Except as provided in subparagraphs 1 through 5, matters deemed necessary by the Minister of Food and Drug Safety for the relevant investigation.
[This Article Newly Inserted by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018]
 Article 62 (Renewal of Permission)
(1) A person who intends to have permission, certification, or notification renewed under Article 49 of the Act shall submit an application in attached Form 51 (including an application in electronic form), along with the relevant permit or certificate, according to the following classifications: <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
1. Where the manufacturing or import permission of medical devices is to be renewed: The Minister of Food and Drug Safety;
2. Where the manufacturing or import certification or the manufacturing or import notification of medical devices is to be renewed: The head of the Information Institute.
(2) Upon receipt of an application for renewal under paragraph (1), the Minister of Food and Drug Safety or the head of the Information Institute shall enter the modified matters in the relevant register and permit or certificate and issue such permit or certificate to the applicant where any of the following matters is modified: <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
1. The classification of classes of medical devices under Article 3 of the Act and the item name according to the classification;
2. The standard specifications under Article 19 of the Act.
 Article 63 (Re-Issuance of Permits)
(1) A medical device manufacturer, importer, repairer, distributor, or lessor who intends to be reissued a permit, certificate, or certificate of notification for reasons recognized by the Minister of Food and Drug Safety, including where the permit, certificate, or certificate of notification is lost, becomes unusable, or becomes subject to any modification, such manufacturer, importer, repairer, distributor, or lessor shall submit an application in attached Form 52 (including an application in electronic form), along with the relevant permit, certificate, or certificate of notification (excluding where the permit, certificate, or certificate of notification is lost), to a person according to the following classifications: <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
1. For a medical device manufacturer or importer:
(a) The manufacturing or import business permit: The head of a regional office of food and drug safety having jurisdiction over the location of the relevant manufacturing or import business place;
(b) The manufacturing or import permit: The Minister of Food and Drug Safety;
(c) The manufacturing or import certificate and the certificate of manufacturing or import notification: The head of the Information Institute;
2. For a medical device repairer: The Mayor/Do Governor having jurisdiction over the location of the relevant repair business place;
3. For a medical device distributor or lessor: The Special Self-Governing Province Governor or the head of a Si/Gun/Gu having jurisdiction over the location of the relevant distribution or leasing business place.
(2) Where reissuing a permit, certificate, or certificate of notification pursuant to paragraph (1), the Minister of Food and Drug Safety, the head of a regional office of food and drug safety, the head of the Information Institute, the Mayor/Do Governor, or the head of a Si/Gun/Gu shall enter the reasons for re-issuance in the relevant register. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
(3) Any person who intends to be confirmed or proved regarding matters permitted, certified, or notified under Article 6 or 15 of the Act shall submit an application in attached Form 53 (including an application in electronic form; for a foreign-language application, the translation thereof) to the Minister of Food and Drug Safety, the head of a regional office of food and drug safety having jurisdiction over the location of the relevant manufacturing or import business place, or the head of the Information Institute. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
 Article 64 (Cooperation in Provision of Data)
Any person who has applied for manufacturing permission or manufacturing certification or has filed a manufacturing notification under Articles 5 through 7 may request that the Minister of Food and Drug Safety or the head of the Information Institute provide specialized institutions or organizations entrusted with the relevant affairs under Article 55 of the Medical Service Act with documents including the relevant applications for manufacturing permission or notifications, and data stating the current status of the procedures for manufacturing permission, etc. In such cases, the Minister of Food and Drug Safety or the head of the Information Institute in receipt of such request may provide the relevant documents and data to such specialized institutions or organizations. <Amended by Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
 Article 65 (Fees)
(1) Fees under Article 50 of the Act shall be as specified in attached Table 10: Provided, That where any matter permitted, certified, or notified is modified, a person who has filed an application or notification shall be exempted from fees, if such person is not responsible for the modification, including where the need for modification arises due to the change of location following the reorganization of administrative districts.
(2) The fees under paragraph (1) may be paid according to the following classifications: <Amended by Ordinance of the Prime Minister No. 1284, Jun. 15, 2016; Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
1. Payment to a State agency: Using electronic money, electronic payment, etc. via the information and communications network (hereafter in this paragraph referred to as "electronic money, etc.") or revenue stamps (in cases of business affairs under the authority of the Minister of Food and Drug Safety, cash or payment receipts verifying cash payment);
2. Payment to a local government: Electronic money, etc. or revenue stamps of the relevant local government;
3. Payment to the Information Institute: Electronic money, etc.
 Article 66 (Re-Examination of Regulation)
The Minister of Food and Drug Safety shall examine the appropriateness of the following matters every three years, counting from each base date specified in the following (referring to the period that ends on the day before the base date of every third year), and shall take measures, such as making improvements:
1. A notification of medical device repair business, a notification of modification thereof, or a notification of business closure or suspension under Article 35: January 1, 2014;
2. A notification of medical device distribution or lease business, a notification of modification thereof, or a notification of business closure or suspension under Article 37: January 1, 2014.
ADDENDA
Article 1 (Enforcement Date)
This Rule shall enter into force on July 29, 2015: Provided, That the amended provisions according to the following classifications shall enter into force on the dates specified in the relevant subparagraphs:
1. The amended provisions pertaining to the manufacturing and quality management systems in Articles 5, 6, 8, 16, 17, 26, 27, 30, 31, and 33, attached Tables 2 through 4, and attached Forms 3, 5, and 29 through 31: January 29, 2016;
2. In the amended provisions of the proviso of Article 9 (2), the provisions providing for the exclusion of medical devices determined and publicly notified by the Minister of Food and Drug Safety as medical devices requiring submission of data regarding clinical trials: January 1, 2016;
3. The amended provisions of subparagraph 2 of attached Table 1: February 1, 2016;
4. In the amended provisions of Article 9 (3), with the exception of its subparagraphs, the provisions providing for the submission to the head of an institution reviewing technical documents: January 1, 2017.
Article 2 (Effective Period)
The amended provisions of Articles 50 (2) and 53 (5) shall be effective until May 10, 2016.
Article 3 (Applicability to Cooperation in Provision of Data)
The amended provisions of Article 64 (including cases applicable mutatis mutandis under Article 34) shall also apply to a person who applies for manufacturing or import permission or files a manufacturing or import notification before this Rule enters into force.
Article 4 (Special Cases concerning Manufacture of In Vitro Diagnostic Drugs and Recognition of Compliance with Quality Management Standards)
With respect to in vitro diagnostic drugs under Article 6 of the Addenda to the Enforcement Rule of the Medical Devices Act (Ordinance of the Prime Minister No. 1081), any person who has obtained permission for manufacturing, distribution, or import of items or has filed a notification of manufacturing, distribution, or import of items pursuant to Article 4 or 5 of the Rule on Safety of Drugs, Etc., as of the enforcement date specified in subparagraph 1 of Article 1 of that Addenda, shall be deemed to have obtained recognition for compliance with the standards under the amended provisions of attached Table 2 by the dates according to the following classifications:
1. Class II in vitro diagnostic devices: November 10, 2016;
2. Class III and Class IV in vitro diagnostic devices: November 10, 2015.
Article 5 (General Transitional Measures)
Any disposition, procedure, or other acts carried out under the previous provisions before this Rule enters into force shall be deemed carried out under the corresponding provisions of this Rule.
Article 6 (Transitional Measures concerning Application of Standards for Administrative Dispositions)
The previous provisions shall apply to administrative dispositions for violations committed before this Rule enters into force.
Article 7 (Transitional Measures concerning Introduction of Standards for Distribution Quality Management)
Any person who has filed a notification of distribution or lease business as of the enforcement date specified in subparagraph 2 of Article 1 of the Addenda to the Enforcement Rule of the Medical Devices Act (Ordinance of the Prime Minister No. 1081) shall comply with the standards prescribed in the amended provisions of attached Table 6 by December 31, 2015.
Article 8 (Transitional Measures concerning Forms)
(1) Any manufacturer or importer under Article 3 of the Addenda to the Medical Devices Act (Act No. 12392) (hereafter in this Article referred to as "manufacturer or importer under the previous provisions"), as at the time the Enforcement Rule of the Medical Devices Act (Ordinance of the Prime Minister No. 1093) enters into force, may continue to use a manufacturing or import business permit issued under the previous provisions until he or she is re-issued the relevant permit under paragraph (2).
(2) Any manufacturer or importer under the previous provisions shall be reissued a manufacturing or import business permit pursuant to the amended provisions of attached Form 2 from the head of a regional office of food and drug safety having jurisdiction over the location of the relevant manufacturing or import business place within three months from July 29, 2016.
Article 9 (Relationship to Other Statutes and Regulations)
(1) Where any of the previous provisions of the Enforcement Rule of the Medical Devices Act is cited by other statutes and regulations as at the time this Rule enters into force and where this Rule includes a corresponding provision, such corresponding provision shall be deemed cited in lieu of the previous provision of this Rule.
(2) Where any in vitro diagnostic reagent or in vitro diagnostic drug under the Rule on Safety of Drugs, Etc. is cited by other statutes and regulations as at the time the Enforcement Rule of the Medical Devices Act (Ordinance of the Prime Minister No. 1081) enters into force, an in vitro diagnostic medical device referred to in this Rule shall be deemed cited in lieu thereof.
ADDENDUM <Ordinance of the Prime Minister No. 1284, Jun. 15, 2016>
This Rule shall enter into force on the date of its promulgation.
ADDENDUM <Ordinance of the Prime Minister No. 1307, Jul. 29, 2016>
This Rule shall enter into force on the date of its promulgation.
ADDENDUM <Ordinance of the Prime Minister No. 1354, Jan. 4, 2017>
This Rule shall enter into force on the date of its promulgation.
ADDENDA <Ordinance of the Prime Minister No. 1389, May 1, 2017>
Article 1 (Enforcement Date)
This Rule shall enter into force on the date of its promulgation.
Article 2 (Applicability to Amounts of Fees)
In the amended provisions of attached Table 10, and attached Forms 3, 5, 7, 8, 30, and 31, the provisions pertaining to the amounts of fees shall begin to apply where an application, notification, or request for review is filed after this Rule enters into force.
Article 3 (Transitional Measures concerning Designation as Institutions Conducting Non-Clinical Studies)
A person conducting non-clinical studies under Article 27 of the Act among the institutions designated as a medical device testing and inspection institution referred to in Article 6 (2) 4 of the Act on Testing and Inspection in the Food and Drug Industry, as at the time this Rule enters into force, shall be deemed designated as an institution conducting non-clinical studies under the amended provisions of Article 24-2: Provided, That such institution shall obtain designation as an institution conducting non-clinical studies under the amended provisions of Article 24-2 within two years from the date this Rule enters into force.
ADDENDA <Ordinance of the Prime Minister No. 1469, Jun. 14, 2018>
Article 1 (Enforcement Date)
This Rule shall enter into force on June 14, 2018: Provided, That the amended provisions of Articles 10, 14 (4) through (9), 32, 51, and 53, Article 63 (1), with the exception of its subparagraphs, and attached Forms 11-2 and 12 shall enter into force on the date of its promulgation; and the amended provisions of Articles 36 and 46-2 shall enter into force on September 14, 2018.
Article 2 (Transitional Measures concerning Minor Repair of Medical Devices)
Notwithstanding the amended provisions of the proviso of subparagraph 1 of Article 36, the previous provisions shall apply where a medical device repairer performs a minor repair of medical devices under the amended provisions of Article 46-2 before this Rule enters into force.
ADDENDA <Ordinance of the Prime Minister No. 1512, Dec. 31, 2018>
Article 1 (Enforcement Date)
This Rule shall enter into force on the date of its promulgation: Provided, That the amended provisions of Articles 52 through 54 and 57 shall enter into force three months after the date of its promulgation; and the amended provisions of Article 54-2 and subparagraph 29-2 of II of attached Table 8 shall enter into force on the date specified in Article 2 (1) 3 of the Addenda.
Article 2 (Enforcement Date of the Medical Devices Act)
(1) "Date prescribed by Ordinance of the Prime Minister" in the main clause of Article 1 of the Addenda to the Medical Devices Act (Act No. 14330) means the date according to the following classifications: <Amended by Ordinance of the Prime Minister No. 1567, Oct. 22, 2019>
1. The amended provisions of the former part of Article 16 (4) and Article 31-4 of the Medical Devices Act (Act No. 14330): The date of the promulgation;
2. The amended provisions of Articles 2 (4), 36 (1) 9-2, and 53-2 of the Medical Devices Act (Act No. 14330): July 1, 2019;
3. The amended provisions of Articles 20, 31-3, 36 (1) 17-3, and 56 (1) 2-3 of the Medical Devices Act (Act No. 14330):
(a) For Class IV medical devices: July 1, 2019;
(b) For Class III medical devices: July 1, 2020;
(c) For Class II medical devices: July 1, 2021;
(d) For Class I medical devices: July 1, 2022;
4. The amended provisions of Articles 31-2, 36 (1) 17-2, and 56 (1) 2-2 of the Medical Devices Act (Act No. 14330): The dates according to the following classifications:
(a) Class IV medical devices: July 1, 2020;
(b) Class III medical devices: July 1, 2021;
(c) Class II medical devices: July 1, 2022;
(d) Class I medical devices: July 1, 2023.
(2) Notwithstanding paragraph (1) 3, the date when the amended provisions of subparagraph 9 of Article 20 and Article 22 of the Medical Devices Act (Act No. 15279) enter into force pursuant to the proviso of Article 1 of the Addenda to that Act shall be July 1, 2019.
Article 3 (Applicability to Recall Procedures of Harmful Medical Devices)
The amended provisions of Articles 52 and 57 shall begin to apply where any medical device is verified as a medical device subject to recall under any subparagraph of Article 52 (2) after this Rule enters into force.
Article 4 (Applicability to Registration of Integrated Medical Device Information)
The amended provisions of Article 54-2 shall begin to apply where any medical device manufacturer or importer supplies medical devices after this Rule enters into force.
Article 5 (Transitional Measures concerning Standards for Administrative Dispositions)
Notwithstanding the amended provisions of attached Table 8, the previous provisions shall apply to any violation committed before this Rule enters into force.
ADDENDUM <Ordinance of the Prime Minister No. 1542, Jun. 12, 2019>
This Rule shall enter into force on June 12, 2019: Provided, That the amended provisions of Article 9 (2) 4 and subparagraph 3 of Article 22 shall enter into force on the date of its promulgation.
ADDENDA <Ordinance of the Prime Minister No. 1567, Oct. 22, 2019>
Article 1 (Enforcement Date)
This Rule shall enter into force on the date of its promulgation: Provided, That the amended provisions of Article 54-2, subparagraph 29-2 of II. Individual Standards of attached Table 8, and attached Form 48-2 shall enter into force on the dates according to the following classifications; and the amended provisions of attached Form 7 shall enter into force one year after the date of its promulgation:
1. Class IV medical devices: July 1, 2020;
2. Class III medical devices: July 1, 2021;
3. Class II medical devices: July 1, 2022;
4. Class I medical devices: July 1, 2023.
Article 2 (Applicability to Entering Resident Registration Numbers in Manufacturing Business Permission Register)
The amended provisions of Article 3 (3) 4 (including cases applicable mutatis mutandis under Article 34) shall also apply to the permission register or notification register for persons who have obtained manufacturing business permission or have filed an import business notification before this Rule enters into force.
Article 3 (Applicability to Reporting on Details of Supply of Medical Devices)
The amended provisions of Article 54-2 shall begin to apply to medical devices supplied in the month following the month in which the amended provisions of the proviso of Article 1 of the Addenda enter into force.
Article 4 (Transitional Measures concerning Application of Standards for Administrative Dispositions)
Notwithstanding the amended provisions of subparagraph 9 (g) of II. Individual Standards of attached Table 8 and subparagraph 12 (f) of that Individual Standards, the previous provisions shall apply where the standards for administrative dispositions against violations committed before this Rule enters into force are applied.
ADDENDUM <Ordinance of the Prime Minister No. 1580, Dec. 23, 2019>
This Rule shall enter into force on the date of its promulgation.