CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to improve public health and contribute to the advancement of in vitro diagnostic medical devices through ensuring safety, improving quality, and strengthening international competitiveness, of such devices by providing for matters necessary for handling, such as manufacturing and import, and management of, and support for the devices.
The terms used in this Act are defined as follows:
| 1. | The term “in vitro diagnostic medical device” means any of the following medical devices under Article 2 (1) of the Medical Devices Act, such as reagents, contrast agents, calibrators, equipment, machine, devices, and software, which are used independently or in combination of others for the purpose of conducting in vitro tests of specimens originated from humans or animals: |
| (a) | Products used for the diagnosis of physiological or pathological conditions; |
| (b) | Products used to determine the causes of diseases or to observe the prognoses of diseases; |
| (c) | Products used to provide information on birth defects; |
| (d) | Products used to provide information required for judgment on safety and suitability in cases of transplantation of tissues or blood donation; |
| (e) | Products used for the purpose of predicting the response to and outcome of treatment; |
| (f) | Products used for the purpose of determining treatment methods or monitoring treatment effects or side effects; |
| 2. | The term "specimen" means tissues, cells, blood, body fluids, urine, feces, etc. collected or extracted from the human body or animals as well as serum, plasma, chromosome, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), protein, etc. separated therefrom; |
| 3. | The term "clinical performance study" means an analysis of specimens to verify results related to clinical, physiological, and pathological conditions for the purpose of demonstrating the performance of in vitro diagnostic medical devices. |
| Article 3 (Classification and Designation of Classes) |
| (1) | The Minister of Food and Drug Safety shall classify and designate classes of in vitro medical devices depending on potential risk to individuals and public health as well as the intended uses of such devices for their systematic and reasonable safety management. |
| (2) | Matters necessary for standards, procedures, etc. for the classification and designation of classes shall be prescribed by Ordinance of the Prime Minister. |
| Article 4 (Relationship to Other Statutes) |
Except as provided in this Act, the Medical Devices Act shall apply to in vitro diagnostic medical devices.
CHAPTER II MANUFACTURING OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
| Article 5 (Permission for Manufacturing Business) |
| (1) | A person who intends to engage in the business of manufacturing in vitro diagnostic medical devices shall obtain manufacturing business permission from the Minister of Food and Drug Safety. In such cases, a person who has obtained manufacturing business permission (hereinafter referred to as “manufacturer”) shall be deemed a person who has obtained manufacturing business permission under the main clause of Article 6 (1), with the exception of its subparagraphs, of the Medical Devices Act only for in vitro diagnostic medical devices. |
| (2) | Notwithstanding paragraph (1), any of the following persons shall not obtain manufacturing business permission: |
| 2. | A person under adult guardianship or under limited guardianship or a person declared bankrupt but not yet reinstated; |
| 3. | A person who is addicted to narcotic drugs, marijuana, or psychotropic drugs; |
| 4. | A person in whose case his or her imprisonment without labor or a heavier punishment declared by a court for violation of this Act or the Medical Devices Act has not been completely executed or the non-execution of such sentence has not become final; |
| 5. | A person in whose case one year has not passed since his or her manufacturing business permission was revoked for violating this Act or the Medical Devices Act (excluding where manufacturing business permission was revoked for reasons prescribed in any of subparagraphs 1 through 3). |
| (3) | A manufacturer shall obtain manufacturing permission or manufacturing certification or file a manufacturing notification according to the following classification with respect to in vitro diagnostic medical devices that he or she intends to manufacture. In such cases, a person who has obtained manufacturing permission or manufacturing certification or has filed a manufacturing notification shall be deemed a person who has obtained manufacturing permission or manufacturing certification or has filed a manufacturing notification under Article 6 (2) of the Medical Devices Act: |
| 1. | In vitro diagnostic medical devices determined and publicly notified by the Minister of Food and Drug Safety as unlikely to pose any risk to individual life or health or public health even upon occurrence of a failure or malfunction of such devices because of little potential risk to individuals and public health: Manufacturing permission, manufacturing certification, or a manufacturing notification, by item category; |
| 2. | In vitro diagnostic medical devices except for those prescribed in subparagraph 1: Manufacturing permission, manufacturing certification, or a manufacturing notification, by item. |
| (4) | Where an application for manufacturing business permission is filed under the former part of paragraph (1), more than one application for manufacturing permission or certification shall be filed together or more than one manufacturing notification shall be filed. |
| (5) | A person who intends to obtain manufacturing business permission under paragraph (1) or a person who intends to obtain manufacturing permission or manufacturing certification or to file a manufacturing notification under paragraph (3) shall be equipped with necessary facilities and manufacturing and quality management systems before filing an application for such permission or certification or filing such notification, as prescribed by Ordinance of the Prime Minister: Provided, That the same shall not apply to cases prescribed by Ordinance of the Prime Minister such as entrusting testing for quality management or manufacturing processes. |
| (6) | A manufacturer shall submit necessary data, such as data on manufacturing and quality management systems, technical documents, and clinical performance study data, to the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister, where he or she intends to obtain manufacturing permission or manufacturing certification or to file a manufacturing notification under paragraph (3). |
| (7) | If permission for manufacturing and distribution of items, manufacturing permission, or manufacturing certification has already been granted or a notification of manufacturing and distribution of items or a manufacturing notification is filed pursuant to Article 31 (2) and (4) of the Pharmaceutical Affairs Act or Article 6 (2) of the Medical Devices Act for in vitro diagnostic medical devices compounded with, or in combination of, drugs or quasi drugs under the Pharmaceutical Affairs Act or medical devices other than in vitro diagnostic medical devices, because their main functions are equivalent to those of drugs or quasi drugs under the Pharmaceutical Affairs Act or medical devices other than in vitro diagnostic medical devices, manufacturing permission or manufacturing certification shall be deemed granted or a manufacturing notification shall be deemed filed under paragraph (3). |
| (8) | A person who intends to obtain manufacturing business permission under paragraph (1) shall employ a quality manager to have him or her perform the affairs under Article 6-2 (1) of the Medical Devices Act, as prescribed by Ordinance of the Prime Minister. |
| (9) | The Minister of Food and Drug Safety shall notify an applicant of whether manufacturing business permission is granted within 25 days from the date of receiving the application for manufacturing business permission under the former part of paragraph (1). |
| (10) | If the Minister of Food and Drug Safety fails to notify an applicant of whether to grant him or her manufacturing business permission or the extension of a period for handling the relevant application under statutes or regulations related to handling civil petitions within the period determined under paragraph (9), such permission shall be deemed granted on the day following the date such period (referring to the extended or re-extended period, where the period is extended or re-extended under statutes or regulations related to handling civil petitions) ends. |
| (11) | Items subject to, and procedures and standards for, manufacturing business permission under the former part of paragraph (1) and manufacturing permission, manufacturing certification, or a manufacturing notification under paragraph (3) and other necessary matters shall be prescribed by Ordinance of the Prime Minister. |
| Article 6 (Concurrent Review of Companion Diagnostic Medical Devices and Drugs) |
| (1) | The Minister of Food and Drug Safety may review the matters related to permission for and a notification of manufacturing and distribution of drug items under Article 31 (2) of the Pharmaceutical Affairs Act and manufacturing permission for, manufacturing certification of, and a manufacturing notification of companion diagnostic medical devices under Article 5 (3) for companion diagnostic medical devices developed together with drugs (referring to in vitro diagnostic medical devices used for the purpose of identifying patients expected to benefit from, or suffer serious side effects for, a prescribed drug or of determining dosage; hereinafter the same shall apply). |
| (2) | Where the Minister of Food and Drug Safety concurrently reviews both drugs and companion diagnostic medical devices under paragraph (1), the documents submitted for the purpose of obtaining permission for manufacturing and distribution or filing a notification of manufacturing and distribution with respect to the relevant drug item under Article 31 (2) of the Pharmaceutical Affairs Act may be deemed documents submitted under Article 5 (6). |
| Article 7 (Clinical Performance Study) |
| (1) | A person who intends to conduct a clinical performance study using in vitro diagnostic medical devices shall prepare a clinical performance study protocol and obtain approval thereof from an institutional review board for clinical performance studies established in a clinical performance study institution under Article 8 (2), and the same shall also apply to any modification of such clinical performance study protocol: Provided, That approval of the clinical performance study protocol or approval for modification thereof shall be obtained from the Minister of Food and Drug Safety in any of the following cases: |
| 1. | Where the method of taking a specimen from the human body causes signigicant risk; |
| 2. | Where it is impossible to verify the results of a clinical performance study with the methods of medical diagnosis already established or in vitro diagnostic medical devices permitted or certified; |
| 3. | Where a clinical performance study is conducted with companion diagnostic medical devices: Provided, That it shall be limited to companion diagnostic medical devices which are not equivalent to medical devices already permitted or certified in terms of intended uses, operating principles, etc. |
| (2) | A person who intends to manufacture or import in vitro diagnostic medical devices for a clinical performance study approved under paragraph (1) shall manufacture such devices in manufacturing facilities that meet the standards prescribed by Ordinance of the Prime Minister or import them which are manufactured in such facilities. In such cases, in vitro diagnostic medical devices may be manufactured or imported without obtaining permission or certification or filing a notification, notwithstanding Articles 5 (3) and 11 (2). |
| (3) | A person who intends to conduct a clinical performance study under paragraph (1) shall comply with the following: |
| 1. | A clinical performance study shall be conducted at a clinical performance study institution designated under Article 8; |
| 2. | A person who is admitted into a collective facility prescribed by Ordinance of the Prime Minister, such as a social welfare facility, (hereafter in this subparagraph, referred to as “admittee”) shall not be selected as the subject of a clinical performance study: Provided, That an admittee may be selected as the subject of a clinical performance study, where it is unavoidable to do so in light of the nature of such clinical performance study and the standards prescribed by Ordinance of the Prime Minister are met; |
| 3. | The in vitro diagnostic medical devices which are manufactured in or imported from facilities that meet the standards referred to in paragraph (2) shall be used; |
| 4. | Where the specimens remaining after use for diagnosis and treatment in medical institutions are used for a clinical performance study, written consent from the specimen provider shall be obtained as prescribed by Ordinance of the Prime Minister: Provided, That the same shall not apply where written consent is exempted under the Bioethics and Safety Act; |
| 6. | Other standards for implementation and management of a clinical performance study shall be observed, as prescribed by Ordinance of the Prime Minister. |
| (4) | The Minister of Food and Drug Safety may take necessary measures including change or revocation of a clinical performance study, if he or she deems that such clinical performance study causes or is likely to cause any risk to public health and hygiene. |
| (5) | Except as provided in paragraphs (1) through (4), matters to be included in a clinical performance study protocol, matters requiring consent from a person subject to a clinical performance study, timing and methods for obtaining such consent, change and revocation of a clinical performance study, and other necessary matters shall be prescribed by Ordinance of the Prime Minister. |
| Article 8 (Clinical Performance Study Institutions) |
| (1) | The Minister of Food and Drug Safety may designate an institution with facilities, specialized personnel, and instruments prescribed by Ordinance of the Prime Minister as a clinical performance study institution among the following institutions: |
| 3. | Other institutions prescribed by Presidential Decree. |
| (2) | A clinical performance study institution designated under paragraph (1) shall establish and operate an institutional review board for clinical performance studies that conducts an independent deliberation on the following, as prescribed by Ordinance of the Prime Minister: |
| 1. | Ethical and scientific validity of a clinical performance study protocol or a modified protocol; |
| 2. | Whether consent is obtained from the human subjects of a clinical performance study according to due process; |
| 3. | Appropriateness of measures to ensure safety and protect personal information of human subjects of a clinical performance study; |
| 4. | Other matters prescribed by Ordinance of the Prime Minister. |
| (3) | If a clinical performance study institution conducts a clinical performance study, it shall prepare and issue a clinical performance study report, retain the relevant record, and observe other requirements prescribed by Ordinance of the Prime Minister. |
| (4) | Except as provided in paragraphs (1) through (3), matters necessary for the procedures, methods, etc. for the designation of a clinical performance study institution shall be prescribed by Ordinance of the Prime Minister. |
| Article 9 (Training for Persons Engaging in Clinical Performance Studies) |
| (1) | The head of a clinical performance study institution and a person who intends to conduct a clinical performance study shall make sure that the following personnel (hereinafter referred to as “persons engaging in clinical performance studies”) receive necessary training to improve their expertise: |
| 1. | A person who is responsible for conducting a clinical performance study at a clinical performance study institution; |
| 2. | A person who is responsible for supervising, verifying, and examining a clinical performance study; |
| 3. | A person who conducts a clinical performance study upon delegation by or under supervision of a responsible person referred to in subparagraph 1. |
| (2) | The Minister of Food and Drug Safety shall order the head of a clinical performance study institution and a person who intends to conduct a clinical performance study to make their persons engaging in clinical performance studies receive training, where deemed necessary to prevent any risk to public health. |
| (3) | Except as provided in paragraphs (1) and (2), matters necessary for details, hours, methods, etc. of training in clinical performance studies shall be prescribed by Ordinance of the Prime Minister. |
| Article 10 (Permission for Modification) |
| (1) | A manufacturer shall obtain permission for or certification of modification from or file a notification of modification with the Minister of Food and Drug Safety, where any modification is made to major matters prescribed by Ordinance of the Prime Minister which have an impact on safety and effectiveness among the matters permitted, certified, or notified under the former part of Article 5 (1) or paragraph (3) of that Article. In such cases, a person who has obtained permission for or certification of modification or filed a notification of modification shall be deemed a person who has obtained permission for or certification of modification or filed a notification of modification under Article 12 (1) of the Medical Devices Act. |
| (2) | Where any matter to be modified does not fall under paragraph (1), a manufacturer shall prepare and keep records on modified matters and report such matters to the Minister of Food and Drug Safety. |
| (3) | The Minister of Food and Drug Safety shall notify an applicant of whether permission for modification of manufacturing business is granted within 15 days from the date of receipt of the application for permission for modification of manufacturing business under paragraph (1). |
| (4) | If the Minister of Food and Drug Safety fails to notify an applicant of whether to grant him or her permission to modify manufacturing business or the extension of a period for handling the relevant application under statutes or regulations related to handling civil petitions within the period determined under paragraph (3), such permission shall be deemed granted on the day following the date such period (referring the extended or re-extended period, where the period is extended or re-extended under statutes or regulations related to handling civil petitions) ends. |
| (5) | Matters necessary for permission for and certification of modification and a notification of modification under paragraph (1) and items subject to, and procedures, methods, deadline, etc. for, reporting modified matters under paragraph (2) shall be prescribed by Ordinance of the Prime Minister. |
| Article 11 (Import Business Permission) |
| (1) | A person who intends to engage in the business of importing in vitro diagnostic medical devices shall obtain import business permission from the Minister of Food and Drug Safety. In such cases, a person who has obtained import business permission (hereinafter referred to as “importer”) shall be deemed a person who has obtained import business permission under Article 15 (1) of the Medical Devices Act only for in vitro diagnostic medical devices. |
| (2) | An importer shall obtain import permission or import certification or file an import notification with regard to in vitro diagnostic medical devices that he or she intends to import, according to the following classifications. In such cases, a person who has obtained import permission or import certification or has filed an import notification shall be deemed a person who has obtained import permission or import certification or filed an import notification under Article 15 (2) of the Medical Devices Act: |
| 1. | In vitro diagnostic medical devices determined and publicly notified by the Minister of Food and Drug Safety as unlikely to pose any risk to individual life or health or public health even upon occurrence of a failure or malfunction of such devices because of little potential risk to individuals or public health: Import permission, import certification, or import notification, by item category; |
| 2. | In vitro diagnostic medical devices except for those prescribed in subparagraph 1: Import permission, import certification, or import notification, by item. |
| (3) | Where an application for import business permission is filed under paragraph (1), more than one application for import permission or import certification shall be filed together or more than one import notification shall be filed. |
| (4) | A person who intends to obtain import business permission under paragraph (1) or a person who intends to obtain import permission or import certification or to file an import notification under paragraph (2) shall be equipped with facilities and manufacturing and quality management systems necessary for quality inspections before filing an application for such permission or certification or filing such notification, as prescribed by Ordinance of the Prime Minister: Provided, That the same shall not apply to cases prescribed by Ordinance of the Prime Minister, such as entrusting testing for quality management. |
| (5) | Article 5 (2), paragraphs (6) through (11) of that Article, and Articles 6 and 10 shall apply mutatis mutandis to in vitro diagnostic medical devices imported under paragraphs (1) through (4) or the importers thereof. In such cases, “manufacturing” shall be construed as “import”, “manufacturing business permission” as “import business permission”, “manufacturing permission” as “import permission”, “manufacturing certification” as “import certification”, “manufacturing notification” as “import notification”, and “manufacturer” as “importer”, respectively. |
| Article 12 (Certification of In Vitro Diagnostic Test in Clinical Laboratories) |
| (1) | Medical institutions under Article 3 of the Medical Service Act and genetic testing institutions under Article 49 of the Bioethics and Safety Act shall be equipped with in vitro diagnostic test system designed and organized by themselves to use such system only in their clinical laboratories, and in cases of conducting a test determined by Ordinance of the Prime Minister, they shall obtain in vitro diagnostic test certification of such clinical laboratories from the Minister of Food and Drug Safety. The same shall also apply to any modification of the matters certified. |
| (2) | Where an application for certification under paragraph (1) is filed, the Minister of Food and Drug Safety shall assess the quality management system of a clinical laboratory, competence of specialized personnel, performance of in vitro diagnostic medical devices, etc.; and where the certification standards prescribed by Ordinance of the Prime Minister are met, he or she may grant certification. |
| (3) | Where certification is granted under paragraph (1), the Minister of Food and Drug Safety shall issue a certificate to an applicant. In such cases, the in vitro diagnostic medical devices included in the in vitro diagnostic test system designed and organized to conduct a test under paragraph (1) shall be deemed in vitro diagnostic medical devices for which manufacturing permission, manufacturing certification, import permission, or import certification has been obtained or a manufacturing notification or an import notification has been filed under Article 5 (3) or 11 (2) only where they are used within a clinical laboratory. |
| (4) | A person who has obtained certification under paragraph (1) shall comply with matters prescribed by Ordinance of the Prime Minister, such as reporting on annual test outcomes, retention of documents related to tests, and compliance with quality management systems. |
| (5) | The Minister of Food and Drug Safety may measure and assess the testing capability of a person who has obtained certification under paragraph (1) to ensure the capability and reliability of such person, as prescribed by Ordinance of the Prime Minister, and where the results are insufficient, he or she may order the person to take corrective measures. |
| (6) | If a person who has obtained certification under paragraph (1) falls under any of the following, the Minister of Food and Drug Safety may revoke the certification: Provided, That certification shall be revoked in cases falling under subparagraph 1: |
| 1. | Where certification is obtained by fraud or other improper means; |
| 2. | Where the certification standards for in vitro diagnostic tests conducted in a clinical laboratory under paragraph (2) are not met; |
| 3. | Where matters to be observed under paragraph (4) are violated; |
| 4. | Where an order for corrective measures under paragraph (5) are not complied with. |
| (7) | The Minister of Food and Drug Safety may entrust part of the affairs regarding certification of an in vitro diagnostic test conducted in a clinical laboratory under paragraph (1) to other institutions or organizations, as prescribed by Presidential Decree. |
| (8) | Matters related to procedures and methods for, and the period of validity of, certification of an in vitro diagnostic test conducted in a clinical laboratory and certification of modification under paragraph (1) and procedures, methods, and other relevant matters for entrusting affairs under paragraph (7) shall be prescribed by Ordinance of the Prime Minister. |
CHAPTER III HANDLING OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
| Article 13 (Labeling on Containers) |
A manufacturer or importer shall label the following descriptions on the container or wrapper of an in vitro diagnostic medical device: Provided, That some of the following descriptions need not be labeled on a container or wrapper prescribed by Ordinance of the Prime Minister, as prescribed by Ordinance of the Prime Minister:
| 3. | The label “In Vitro Diagnostic Medical Device"; |
| 4. | Methods of keeping and storage; |
| 5. | Other matters determined by Ordinance of the Prime Minister. |
| Article 14 (Labeling on Outside Package) |
If a description labeled on the container or wrapper of an in vitro diagnostic medical device under Article 13 is covered by an outside container or package and it is impossible to read such description, a manufacturer or importer shall label the same description on the outside container or package.
| Article 15 (Labeling on Package Inserts) |
| (1) | A manufacturer or importer shall state the following in the package inserts of in vitro diagnostic medical devices: |
| 1. | The methods and precautions for use; |
| 2. | Matters related to quality control (referring to activities such as performance tests to ensure the quality of in vitro diagnostic medical devices; hereinafter the same shall apply), if necessary; |
| 4. | Other matters determined by Ordinance of the Prime Minister. |
| (2) | A manufacturer or importer may provide package inserts under paragraph (1) in any of the following form: |
| 2. | Electronic media such as USB or CD; |
| 3. | Websites (limited to in vitro diagnostic medical devices designated by the Minister of Food and Drug Safety, mainly used by medical institutions under Article 3 of the Medical Service Act). |
CHAPTER IV MANAGEMENT AND SUPERVISION
| Article 16 (Reporting and Inspection) |
| (1) | If deemed necessary to prevent risk, manage quality, maintain order in distribution, or manage and supervise a clinical performance study institution or a clinical laboratory related to in vitro diagnostic medical devices or to perform other relevant acts, the Minister of Food and Drug Safety may require a manufacturer, importer, clinical performance study institution, or clinical laboratory to file a necessary report or require relevant public officials to perform any of the following activities: |
| 1. | Accessing the plants, warehouses, stores, offices, clinical performance study institutions, clinical laboratories, or other places that handle in vitro diagnostic medical devices to inspect facilities therein, relevant books or documents, or other objects, or to ask questions to relevant persons; |
| 2. | Collecting a minimum quantity of in vitro diagnostic medical devices which are suspected to violate Article 26 of the Medical Devices Act or which are deemed likely to cause significant damage to or have a fatal impact on public health at time of use, or in vitro diagnostic medical devices required for tests or quality inspections. |
| (2) | A public official who intends to access places, conduct inspections, ask questions, or collect devices under paragraph (1) shall carry an identification verifying his or her authority and present it to relevant persons. |
| (3) | The authority of relevant public officials, the scope of their duties, the identification referred to in paragraphs (1) and (2), and other necessary matters shall be prescribed by Ordinance of the Prime Minister. |
| Article 17 (Inspection Order) |
Where the relevant in vitro diagnostic medical device is deemed likely to cause any risk to public health, the Minister of Food and Drug Safety may order a manufacturer or importer to undergo an inspection conducted by a clinical performance study institution or medical device testing and inspection institution designated by the Minister of Food and Drug Safety under Article 6 (2) 4 of the Act on Testing and Inspection in the Food and Drug Industry.
| Article 18 (Revocation of Permission and Suspension of Business Affairs) |
| (1) | Where a manufacturer or importer of in vitro diagnostic medical devices falls under any of the following, the Minister of Food and Drug Safety may revoke the relevant permission or certification, prohibit the manufacturing, import, and distribution of the relevant item category or item, or issue an order to suspend all or part of business affairs for up to one year: Provided, That in cases falling under subparagraph 1, 10, or 11, permission or certification shall be revoked: |
| 1. | Where a manufacturer or importer falls under any of the subparagraphs of Article 5 (2) (including cases applied mutatis mutandis in Article 11 (5)): Provided, That the same shall not apply where an heir has transferred the status of a manufacturer or importer within six months under Article 47 (2) of the Medical Devices Act; |
| 2. | Where a manufacturer or importer manufactures or imports in vitro diagnostic medical devices without obtaining permission or certification or filing a notification, in violation of Article 5 (3) or 11 (2); |
| 3. | Where a manufacturer or importer fails to have facilities and manufacturing and quality management systems in accordance with the main clause of Article 5 (5) and the main clause of Article 11 (4); |
| 4. | Where a manufacturer or importer manufactures in vitro diagnostic medical devices for a clinical performance study in a manufacturing facility not in compliance with standards or imports in vitro diagnostic medical devices manufactured in such facility, in violation of Article 7 (2); |
| 5. | Where a manufacturer or importer fails to obtain permission for or certification of modification or to file a notification of modification in violation of Article 10 (including cases applied mutatis mutandis in Article 11 (5)), or fails to file a report on modified matters or files a falsified report thereon; |
| 7. | Where a manufacturer or importer refuses, interferes with, or evades the access, inspection, questioning, or collection by relevant public officials under Article 16 (1); |
| 8. | Where a manufacturer or importer fails to follow an inspection order under Article 17; |
| 9. | Where a manufacturer or importer manufactures, imports, or distributes an in vitro diagnostic medical device that causes, or is likely to cause, any risk to public health, or an in vitro diagnostic medical device deemed to have no performance, efficacy, or effect; |
| 10. | Where a manufacturer or importer has no facilities at the location for which manufacturing business permission or import business permission is granted; |
| 11. | Where a manufacturer or importer conducts business affairs during a business suspension period. |
| (2) | The standards for the administrative dispositions under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. |
| Article 19 (Revocation of Designation) |
| (1) | Where a clinical performance study institution designated under Article 8 (1) falls under any of the following, the Minister of Food and Drug Safety may revoke its designation or order suspension of business affairs for a specified period not exceeding six months: Provided, That designation shall be revoked in cases falling under subparagraph 1, 2, or 5: |
| 1. | Where it has obtained designation by fraud or other improper means; |
| 2. | Where it prepares and issues a falsified clinical performance study report intentionally or by gross negligence; |
| 3. | Where it fails to meet the standards for designation of a clinical performance study institution; |
| 4. | Where it fails to comply with any of the matters to be observed under Article 8 (3); |
| 5. | Where it conducts business affairs during a business suspension period. |
| (2) | An institution whose designation has been revoked under paragraph (1) shall not be re-designated within three years from the date designation is revoked. |
| (3) | The standards for the administrative dispositions under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. |
| Article 20 (Imposition of Penalty Surcharges) |
| (1) | Where the suspension of business affairs is ordered under Article 18 (1) and where any substantial inconvenience is likely to be caused to users of in vitro diagnostic medical devices or public interests are likely to be undermined, the Minister of Food and Drug Safety may impose a penalty surcharge not exceeding one billion won in lieu of the suspension of business affairs, as prescribed by Presidential Decree. |
| (2) | Matters necessary for the types of violations for which a penalty surcharge is imposed under paragraph (1), the amount of a penalty surcharge based upon the severity, etc. of a violation, and other necessary matters shall be prescribed by Presidential Decree. |
| (3) | Where necessary for the collection of a penalty surcharge, the Minister of Food and Drug Safety may request the head of a competent tax office to provide taxation information including the following: |
| 1. | The personal information of a taxpayer; |
| 3. | Data about the amount of distribution that serves as the basis for the imposition of the penalty surcharge. |
| (4) | If a person obligated to pay a penalty surcharge fails to pay it by the payment deadline, the Minister of Food and Drug Safety shall revoke the imposition of the penalty surcharge under paragraph (1) and then suspend business affairs under Article 18 (1) or collect the penalty surcharge in the same manner as delinquent national taxes are collected, as prescribed by Presidential Decree: Provided, That where it is impossible to suspend business affairs under Article 18 (1) due to business closure, etc., the penalty surcharge shall be collected in the same manner as delinquent national taxes are collected. |
| (5) | The penalty surcharges imposed and collected by the Minister of Food and Drug Safety pursuant to paragraphs (1) through 4 shall devolve on the State. |
CHAPTER V SUPPLEMENTARY PROVISIONS
| Article 21 (Committee of Experts on In Vitro Diagnostic Medical Devices) |
| (1) | A Committee of Experts on In Vitro Diagnostic Medical Devices shall be established within the Ministry of Food and Drug Safety to investigate and deliberate on matters regarding permission for and safety management of in vitro diagnostic medical devices in response to a request for advice from the Minister of Food and Drug Safety. |
| (2) | The Committee of Experts on In Vitro Diagnostic Medical Devices shall be composed of not less than 10 but not more than 20 experts including one chairperson. |
| (3) | The chairperson shall be the Vice Minister of Food and Drug Safety, and experts shall be commissioned by the Minister of Food and Drug Safety from among the following persons: |
| 1. | Persons who have abundant expertise and experience in the fields of health care and in vitro diagnostic medical devices; |
| (4) | Except as provided in paragraphs (1) through (3), matters necessary for the establishment and operation of the Committee of Experts on In Vitro Diagnostic Medical Devices and other relevant matters shall be prescribed by Presidential Decree. |
| Article 22 (Technical Support) |
| (1) | The Minister of Food and Drug Safety may conduct the following projects to ensure the safety and effectiveness of in vitro diagnostic medical devices: |
| 1. | Research on a management system for in vitro diagnostic medical devices; |
| 2. | Support for clinical performance studies of in vitro diagnostic medical devices and other tests or inspections; |
| 3. | Support for facilities and manufacturing and quality management systems for in vitro diagnostic medical devices; |
| 4. | Support for standardization of standard specifications, etc. and establishment, revision, and publication of standards; |
| 5. | Other technical support projects to ensure the safety and effectiveness of in vitro diagnostic medical devices. |
| (2) | The Minister of Food and Drug Safety may entrust the support projects referred to in paragraph (1) to a relevant specialized institution or organization and assist with the expenses incurred in such projects, as prescribed by Presidential Decree. |
| (3) | Matters necessary for targets, procedures, methods, and operation of projects under paragraphs (1) and (2) and other relevant matters shall be prescribed by Ordinance of the Prime Minister. |
| Article 23 (Promotion of Collection and Use of Information on In Vitro Diagnostic Medical Devices) |
The Minister of Food and Drug Safety may collect various knowledge and information, such as domestic and overseas clinical information related to the safety and effectiveness of in vitro diagnostic medical devices, establish a database, and provide such database to a manufacturer, etc.: Provided, That personal information under subparagraph 1 of Article 2 of the Personal Information Protection Act shall be excluded.
| Article 24 (Manufacturing of Reference Standards for In Vitro Diagnostic Medical Devices) |
| (1) | The Minister of Food and Drug Safety may manufacture, establish, manage, and distribute reference standards to be used for performance evaluation or quality management of in vitro diagnostic medical devices. |
| (2) | The Minister of Food and Drug Safety may preferentially distribute reference standards, where deemed necessary to protect human life and health from public health risk. |
| (3) | Matters necessary for manufacturing, establishment, management, and distribution of reference standards under paragraphs (1) and (2) and other relevant matters shall be determined and publicly notified by the Minister of Food and Drug Safety. |
The Minister of Food and Drug Safety shall hold a hearing, if he or she intends to issue any of the following administrative dispositions:
| 1. | Revocation of permission or certification, prohibition of manufacturing, import, or distribution of an item category or item, or suspension of all or part of business affairs under Article 18; |
| Article 26 (Delegation and Entrustment of Authority) |
| (1) | The Minister of Food and Drug Safety may delegate part of his or her authority bestowed by this Act to the head of a regional office of food and drug safety or the Director General of the National Institute of Food and Drug Safety Evaluation, as prescribed by Presidential Decree. |
| (2) | The Minister of Food and Drug Safety may entrust affairs concerning the certification or notification of in vitro diagnostic medical devices under this Act to the National Institute of Medical Device Safety Information under Article 42 of the Medical Devices Act, as prescribed by Presidential Decree. |
| (3) | The Minister of Food and Drug Safety may entrust part of the affairs under this Act to an institution or organization related to in vitro diagnostic medical devices, as prescribed by Presidential Decree. |
| Article 27 (Legal Fiction as Public Officials in Application of Penalty Provisions) |
| Article 28 (Special Cases concerning In Vitro Diagnostic Medical Devices for Animals) |
| (1) | Among matters within the jurisdiction of the Minister of Food and Drug Safety under this Act, those related to in vitro diagnostic medical devices exclusively used for animals shall fall under the jurisdiction of the Minister of Agriculture, Food and Rural Affairs. In such cases, "the Minister of Food and Drug Safety" in the relevant provisions of this Act shall be construed as "the Minister of Agriculture, Food and Rural Affairs" and "Ordinance of the Prime Minister" as "Ordinance of the Ministry of Agriculture, Food and Rural Affairs", respectively. |
| (2) | When the Minister of Agriculture, Food and Rural Affairs prescribes Ordinance of the Ministry of Agriculture, Food and Rural Affairs under paragraph (1), he or she shall consult with the Minister of Food and Drug Safety in advance. |
CHAPTER VI PENALTY PROVISIONS
| Article 29 (Penalty Provisions) |
| (1) | Any of the following persons shall be punished by imprisonment with labor for not more than three years or by a fine not exceeding 30 million won: |
| 1. | A person who fails to obtain approval of a clinical performance study protocol or approval for modification thereof, in violation of Article 7 (1); |
| 2. | A person who manufactures in vitro diagnostic medical devices in a manufacturing facility not in compliance with standards or imports in vitro diagnostic medical devices manufactured in such facility, in violation of the former part of Article 7 (2); |
| 3. | A person who violates the requirements for a clinical performance study under Article 7 (3); |
| 4. | A person who fails to obtain permission for or certification of modification or to file a notification of modification, in violation of Article 10 (1) (including cases applied mutatis mutandis in Article 11 (5)). |
| (2) | Imprisonment with labor and a fine under paragraph (1) may be imposed concurrently. |
| Article 30 (Penalty Provisions) |
A person who prepares or issues a falsified clinical performance study report shall be punished by imprisonment with labor for not more than one year or by a fine not exceeding 10 million won.
| Article 31 (Penalty Provisions) |
Any of the following persons shall be punished by a fine not exceeding five million won:
| 2. | A person who refuses, interferes with, or evades the access, inspection, questioning, or collection by relevant public officials under Article 16 (1); |
| 3. | A person who fails to follow an inspection order or an order of suspension of business affairs under Article 17 or 18; |
| 4. | A person who commits any violation falling under Article 19 (1) 1 or 5. |
| Article 32 (Joint Penalty Provisions) |
If the representative of a corporation or an agent, employee of, or any other person employed by a corporation or an individual commits an offense described in Articles 29 through 31 in conducting the business affairs of the corporation or individual, not only shall the offender be punished but the corporation or individual shall be punished by a fine prescribed in the relevant Article: Provided, That the same shall not apply where such corporation or individual has not been negligent in giving due attention and supervision concerning the relevant business affairs to prevent such offense.
| Article 33 (Administrative Fines) |
| (1) | A person who fails to make persons engaging in clinical performance studies receive training in violation of Article 9 (1) and (2) shall be subject to a fine not exceeding one million won. |
| (2) | Administrative fines under paragraph (1) shall be imposed and collected by the Minister of Food and Drug Safety, as prescribed by Presidential Decree. |
ADDENDA
Article 1 (Enforcement Date)
This Act shall enter into force one year after the date of its promulgation.
Article 2 (Applicability to Labeling on Containers)
Articles 13 through 15 shall begin to apply to in vitro diagnostic medical devices taken out from a factory or bonded area on or after the date this Act enters into force. Article 3 (Transitional Measures concerning Permission, Certification, and Notification)
| (1) | A person who has obtained manufacturing business permission or import business permission under the Medical Devices Act as at the time this Act enters into force and manufactures or imports in vitro diagnostic medical devices shall be deemed to have obtained permission under Article 5 (1) or 11 (1): Provided, That he or she shall have facilities and manufacturing and quality management systems under the main clause of Article 5 (5) or the main clause of Article 11 (4) within two years after this Act enters into force. |
| (2) | Where manufacturing permission, manufacturing certification, import permission, or import certification has been obtained or a manufacturing notification or import notification has been filed regarding in vitro diagnostic medical devices under the Medical Devices Act as at the time this Act enters into force, permission or certification shall be deemed obtained or a notification shall be deemed filed under Article 5 (3) or 11 (2). |
Article 4 (Transitional Measures concerning Clinical Performance Study Institution)
An institution that has been designated as a clinical trial institution under Article 10 (3) of the Medical Devices Act as at the time this Act enters into force shall be deemed designated as a clinical performance study institution under Article 8 (1): Provided, That the institution shall apply for re-designation as a clinical performance study institution under this Act within one year after this Act enters into force. Article 5 (Transitional Measures concerning Labeling on Containers)
A container, package, or package insert on which descriptions are labeled under Articles 20 through 22 of the Medical Devices Act as at the time this Act enters into force may be used for two years from the enforcement date of this Act, notwithstanding Articles 13 through 15. Article 6 (Transitional Measures concerning Dispositions)
Public notice, dispositions, and other acts issued or taken by administrative agencies or applications, notifications, or other acts filed with or taken toward administrative agencies under the Medical Devices Act with regard to in vitro diagnostic medical devices before this Act enters into force shall be deemed acts taken by or toward administrative agencies under this Act. Article 7 (Transitional Measures concerning Administrative Dispositions)
Article 8 (Transitional Measures concerning Penalty Provisions)
Article 9 (Relationship to Other Statutes or Regulations)
Where the Medical Devices Act or any provision thereof is cited by other statutes or regulations as at the time this Act enters into force, and if provisions corresponding thereto exist herein, this Act or the relevant provisions thereof shall be deemed cited.