CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to contribute to the promotion of the public health, job creation and development of the national economy by laying the foundation for the development of the medical devices industry by nurturing and supporting the industry and promoting the commercialization of innovative medical devices, thereby strengthening the competitiveness of the medical devices industry.
The terms used in this Act shall be defined as follows:
| 1. | The term “medical devices industry” means the industry related to research and development, manufacturing, import, repair and distribution of medical devices under Article 2 (1) of the Medical Devices Act; |
| 2. | The term “medical devices company” means a company that is engaged in economic activities related to the medical devices industry in Korea and falls under any of the following categories: |
| a. | A company which obtained medical devices manufacturing business permission in accordance with Article 6 of the Medical Devices Act and acquired manufacturing business permission or manufacturing certification regarding the medical devices to be manufactured or filed a manufacturing notification of such medical devices; |
| b. | A company which obtained medical devices import business permission in accordance with Article 15 of the Medical Devices Act and acquired import permission or certification regarding the medical devices to be imported or filed an import notification of such medical devices; |
| 3. | The term “innovative medical devices company” means the company that falls under one of the following categories and obtained certification from the Minister of Health and Welfare according to Article 10: |
| a. | Medical devices company that has invested in the research and development of medical devices, which is higher than the amount defined by the Presidential Decree; |
| b. | A foreign-invested company, which has invested in the research and development of medical devices more than the amount defined in Presidential Decree in Korea or a foreign-invested medical devices company in accordance with Article 2 (1) 6 of the Foreign Investment Promotion Act; |
| c. | Medical devices company which has conducted research and development and produces innovative medical devices designated under Article 21; |
| 4. | The term “innovative medical devices” means medical devices which have improved or are expected to improve the safety and effectiveness compared to existing medical devices or therapy by applying advanced technology which is technology intensive and rapid in terms of innovation such as information and communications technology, biotechnology and robotic technology or by improving the methodology for use among the medical devices defined in Article 2 (1) of the Medical Devices Act; and medical devices which are designated by the Minister of Food and Drug Safety under Article 21. |
| Article 3 (Responsibilities of the State and Local Governments) |
| (1) | The State and local governments shall establish and implement measures necessary for the formation of the foundation for medical devices industry and strengthening competitiveness of the industry, such as promoting the development and commercialization of medical devices. |
| (2) | The State and local governments may provide administrative and financial support for research and development and improvement of research and production facilities of the innovative medical devices companies. |
| (3) | The State and local governments shall actively make an effort to expand the investment of medical devices companies on research and development and attract investment in the research and development of innovative medical devices from foreign investment companies. |
| Article 4 (Responsibilities of Medical Devices Companies) |
| (1) | Medical devices companies shall contribute to laying the foundation for the development of the medical devices industry and the improvement of the public health by developing medical devices industry systematically and strengthening innovation. |
| (2) | Medical devices companies shall actively respond to institutional improvement for improving the quality of medical devices, such as complying with the manufacturing and quality control standards of medical devices. |
| (3) | Medical devices companies shall cooperate to enhance the transparency of the medical devices industry, such as the establishment of measures to crack down on corruption and illegal activities related to medical devices. |
| Article 5 (Relationship with Other Acts) |
CHAPTER II ESTABLISHMENT OF MEDICAL DEVICES INDUSTRY MASTER PLAN
| Article 6 (Establishment of Master Plan) |
| (1) | The Minister of Health and Welfare shall establish the master plan on nurturing and supporting the medical devices industry (hereinafter referred to as “master plan”) every five years in order to lay the foundation for the development of the medical devices industry and strengthen international competitiveness. |
| (2) | Master plan shall include the following: |
| 1. | Mid to long-term goal to nurture the medical devices industry; |
| 2. | Plan for financing and utilization of finance required to nurture the medical devices industry; |
| 3. | Plan for the development and efficient utilization of human resources necessary to nurture the medical devices industry; |
| 4. | Plan to support international cooperation and entry into overseas markets for the medical devices industry; |
| 5. | Plan to support including research and development and commercialization of innovative medical devices, etc.; |
| 6. | Plan to support innovative medical devices companies; |
| 7. | Plan to attract investment in research and development of medical devices from foreign-investment companies; |
| 8. | Other matters that are required to nurture the medical devices industry and defined by Presidential Decree. |
| (3) | The Minister of Health and Welfare shall consult with the head of relevant central administrative agencies when establishing the master plan. |
| (4) | Master plan shall be finalized after the deliberation by medical devices industry promotion and support committee in accordance with Article 8. The same shall also apply to the case of revising the master plan. |
| (5) | The Minister of Health and Welfare shall notify the head of the relevant central administrative agencies of the master plan determined and revised in accordance with paragraph (4). |
| (6) | If the Minister of Health and Welfare finds it necessary for the establishment of the master plan, he or she may request the head of the concerned authority to submit the data necessary for the establishment of the master plan. In such cases, the head of the relevant authority shall submit the requested data if there is no justifiable reason. |
| Article 7 (Establishment of Implementation Plan) |
| (1) | The Minister of Health and Welfare and the heads of the Central Administrative Agencies concerned shall establish and implement a yearly implementation plan (hereinafter referred to as “implementation plan”) based on the master plan. |
| (2) | The head of the central administrative body concerned shall submit the implementation plan for the next year and actual outcome of the previous year’s implementation plan to the Minister of Health and Welfare every year as prescribed by Presidential Decree. |
| (3) | The Minister of Health and Welfare shall evaluate the achievements based on the previous year’s implementation plan and notify the heads of relevant central administrative agencies of the result. |
| (4) | If the Minister of the Health and Welfare and the heads of the central administrative agencies concerned find it necessary to establish the implementation plan, they may request the heads of relevant organizations to submit the data required for the establishment of an implementation plan. In such cases, the heads of the relevant organizations shall submit the data if there is no justifiable reason. |
| (5) | Matters necessary for the establishment and implementation of the implementation plan and for the evaluation of results shall be determined by Presidential Decree. |
| Article 8 (Medical Devices Industry Promotion and Support Committee) |
| (1) | For the purpose of deliberating the followings, there shall be the Medical Devices Industry Promotion and Support Committee (hereinafter referred to as the “Committee” under the Minister of Health and Welfare: |
| 1. | Matters related to the establishment and implementation of a master plan and implementation plan; |
| 2. | Matters related to certification, revocation of certification and succession of innovative medical devices companies; |
| 3. | Matters related to the designation of an innovative medical devices group; |
| 4. | Others that are necessary for the promotion and support for the medical devices industry and defined by Presidential Decree. |
| (2) | The Committee is composed of less than 15 members, including one chairperson. |
| (3) | The chairperson of the Committee shall be the Minister of Health and Welfare and members of the Committee shall be composed of ex officio members and appointed members. In such cases, the number of appointed members shall be the majority of the total members: |
| 1. | Ex officio members: The person appointed by a relevant authority among vice minister level government officials of the central administrative body concerned as defined by Presidential Decree and the Vice Minister of Food and Drug Safety; |
| 2. | Appointed members: Members with abundant knowledge and experience in the medical devices industry working for the industry or academia and appointed by the chairperson of the Committee. In such cases, two members respectively recommended by the Minister of Science and ICT, the Minister of Trade, Industry and Energy and the Minister of Food and Drug Safety shall be included. |
| (4) | If a member of the Committee falls under any of the following categories, he or she shall be excluded from the deliberation of the agenda: |
| 1. | If the member or the corporation or group to which the member belongs have a direct interest in the agenda subject to deliberation; |
| (5) | If the party related to the agenda subject to deliberation has some reason for not expecting the fair execution of matters, he or she may apply for avoidance and if the Committee recognizes that the application is reasonable, exclusion of the concerned member shall be determined. |
| (6) | If the member falls under the category of paragraph (4) or (5), he or she shall avoid the deliberation of the agenda involved by himself or herself. |
| (7) | There may be working-level committee under the Committee for the purpose of executing works efficiently. |
| (8) | There shall be two coordinators in the Committee to handle office works of the Committee and coordinators shall be designated by the Minister of Health and Welfare and the Minister of Food and Drug Safety respectively among government officials working for the Ministry of Health and Welfare and Ministry of Food and Drug Safety. |
| (9) | Matters except for items defined from paragraphs (1) through (8), related to the establishment and operation of the Committee and working-level committee shall be determined by Presidential Decree. |
| Article 9 (Survey on Actual Situation) |
| (1) | The Minister of Health and Welfare shall carry out survey on the current status of the medical devices industry home and abroad every three years and publish the results in order to establish and implement the master plan and implementation plan effectively. |
| (2) | The Minister of Health and Welfare may request the heads of central administrative agencies, heads of local governments, heads of medical organizations and heads of relevant organizations and groups to submit data or to cooperate with the survey under paragraph (1) if necessary. In such cases, the requested party shall submit data or cooperate if there is no justifiable reason. |
| (3) | Matters necessary for the scope, method and process of the survey under paragraph (1) shall be determined by Presidential Decree. |
CHAPTER III CERTIFICATION OF AND SUPPORT FOR INNOVATIVE MEDICAL DEVICES COMPANIES
SECTION 1 Certification of Innovative Medical Devices Companies
| Article 10 (Certification of Innovative Medical Devices Companies) |
| (1) | A medical devices company that intends to be certified as an innovative medical devices company shall apply for the certification of an innovative medical devices company to the Minister of Health and Welfare as stated in Ordinance of the Ministry of Health and Welfare. |
| (2) | The Minister of Health and Welfare may certify the company which applied for certification under paragraph (1) as an innovative medical devices company after going through deliberation at the Committee. In such cases, the certification standards shall be determined by Presidential Decree considering the following matters: |
| 1. | Excellence in human and material input resources such as securing research personnel in the medical devices sector and preparation of production facilities for research and development; |
| 2. | Excellence in research and development activities such as R&D planning on medical devices and mid to long-term R&D investment plan; |
| 3. | Technical and economic excellence of the medical devices R&D outcome and contribution to the improvement of public health; |
| 4. | Corporate social responsibilities and ethics such as compliance with distribution and sales system of the medical devices. |
| (3) | The Minister of Health and Welfare shall issue a certificate to the companies certified according to paragraph (2) and shall make an indication of the certification (hereinafter referred to as “certification mark”) for use by certified innovative medical devices companies. |
| (4) | No one shall make and use a certificatee or certification mark without obtaining the certification under paragraph (2) or shall impersonate the certification in any way. |
| (5) | Matters including certification method and procedure under paragraph (2) and drawing and representation of certification mark under paragraph (3) shall be determined by Ordinance of the Ministry of Health and Welfare. |
| Article 11 (Succession of Status) |
| (1) | A company which wants to succeed the status of an innovative medical devices company shall apply for the succession of the status to the Minister of Health and Welfare. In such cases, the matters including the method of application for the succession of status and procedures shall be determined by Ordinance of the Ministry of Health and Welfare. |
| (2) | The Minister of Health and Welfare may decide whether to approve the succession of status or not considering the matters defined by Ordinance of Ministry of Health and Welfare based on deliberation by the Committee if there is an application under paragraph (1): Provided, That in case where the applicant under paragraph (1) falls under any of the following categories, the decision on the succession of status may be made without going through deliberation process by the Committee: |
| 1. | If there is a division of an innovative medical devices company (including merger after division of an innovative medical devices company), corporation which maintains or succeeds all businesses related to the medical devices industry; |
| 2. | A medical devices company, which can meet the purpose of certification such as meeting the certification criteria under Article 10 and satisfies the requirements defined by Presidential Decree. |
| Article 12 (Validity Period of Certification) |
| (1) | The validity of the certification under Article 10 (2) shall be three years from the date of certification. |
| (2) | The Minister of Health and Welfare may extend the certification by reassessing the company every three years after initial certification. |
| (3) | The matters including the reassessment criteria under paragraph (2) and application for extension of certification shall be determined by Ordinance of the Ministry of Health and Welfare. |
| Article 13 (Cancellation of Certification) |
| (1) | The Minister of Health and Welfare may revoke the certification after deliberation by the Committee if the companies certified as an innovative medical devices company in accordance with Article 10 (2) falls under any of the following categories: Provided, That certification shall be canceled in case of subparagraph 1: |
| 1. | If the company obtained certification by false or other fraudulent means; |
| 2. | If the company does not meet the certification criteria anymore; |
| (2) | The Minister of Health and Welfare shall not certify a medical devices company whose certification has been canceled under paragraph (1) 1 if three years have not been passed since the date of cancellation. |
| (3) | The State or a local government shall suspend the support of various preferential treatment provided in accordance with Articles 16 through 19 to medical devices companies whose certification has been canceled for the reason given in paragraph (1) 1. They may take action to make the company whose certification has been canceled to return the benefits provided from the date of certification to the date of cancellation of certification. |
| (4) | The State or a local government shall cease to provide preferential treatments provided in accordance with Articles 16 through 19 to medical devices companies whose certification has been canceled for the reasons referred to in paragraph (1) 2 or 3. |
| (5) | Matters necessary for cancellation of certification under paragraph (1), suspension of preferential treatment under paragraphs (3) and (4) and process of returning benefits shall be determined by Presidential Decree. |
| Article 14 (Provision of Data) |
| (1) | Companies which applied for certification of an innovative medical devices company under Article 10 or innovative medical devices companies shall cooperate with the Minister of Health and Welfare if the Minister requests the submission of data necessary for works related to certification or cancellation of certification. |
| (2) | The matters including the scope of data under paragraph (1) and procedures shall be determined by Ordinance of the Ministry of Health and Welfare. |
| Article 15 (Classification of Innovative Medical Devices Companies by Type) |
| (1) | The classification of innovative medical devices companies shall be determined by Presidential Decree within the scope defined in Article 2 (3). |
| (2) | The government may change the method and scale of support for each category of an innovative medical devices company under paragraph (1) as prescribed by Ordinance of the Ministry of Health and Welfare. |
SECTION 2 Support for Innovative Medical Devices Companies
| Article 16 (Preferential Treatment regarding National R&D Projects) |
| (1) | The State or local governments may allow innovative medical devices companies to participate in national R&D projects for medical devices first. |
| (2) | The method and process of participation as a preferred participant under paragraph (1) shall be determined by Ordinance of the Ministry of Health and Welfare. |
| Article 17 (Special Cases concerning Taxation) |
| Article 18 (Special Cases concerning Research Facility Construction) |
| (1) | Innovative medical devices companies may establish research facilities (including the facilities such as prototype production facilities and other facilities recognized for an auxiliary purpose as stipulated in Presidential Decree) in one of the areas under Article 36 of the National Land Planning and Utilization Act ( excluding the areas determined by Presidential Decree such as green area) despite the restrictions in Article 76 (1) of the same Act as announced by the Minister of Health and Welfare in consultation with the Minister of the Ministry of Land, Infrastructure and Transport. |
| (2) | The matters under paragraph (1) including the procedure of announcement shall be determined by Presidential Decree. |
[Act No. 16405 (Apr. 30, 2019) This Article shall be effective until April 30, 2030 pursuant to Article 2 of the Addenda.]
| Article 19 (Exemption of Various Kinds of Charges) |
For the research facilities of the innovative medical devices companies, the following charges may be exempted:
[Act No. 16405 (Apr. 30, 2019) This Article shall be effective until April 30, 2030 pursuant to Article 2 of the Addenda.]
CHAPTER IV DESIGNATION OF AND SUPPORT FOR INNOVATIVE MEDICAL DEVICES
| Article 20 (Designation of Innovative Medical Devices Group) |
| (1) | The Minister of Health and Welfare may designate the innovative medical devices group after deliberation by the Committee to promote the development of medical devices technology, improve treatment method remarkably and improve the quality of life of the public through treatment of rare and incurable diseases. |
| (2) | The designation of innovative medical devices group under paragraph (1) shall be valid for three years from the date of designation and the Minister of Health and Welfare may extend the designation period through reassessment every three years after the designation of the innovative medical devices group. |
| (3) | The Minister of Health and Welfare shall notify the innovative medical devices group designated in accordance with the paragraph (1). |
| (4) | Matters necessary for the designation and reassessment of the innovative medical devices group under paragraphs (1) and (2) shall be determined by Presidential Decree. |
| Article 21 (Designation and Cancellation of Innovative Medical Devices) |
| (1) | Those who intend to obtain the designation of a medical device that is included in the innovative medical device group as an innovative medical device shall apply for the designation to the Minister of Food and Drug Safety. |
| (2) | The Minister of Food and Drug Safety may designate the medical devices for which application for the designation as an innovative medical device under paragraph (1) was made considering the following subparagraphs. In such cases, the Minister of Food and Drug Safety shall consult with the Minister of Health and Welfare if he or she wants to designate the medical device as an innovative medical device: |
| 1. | Whether the technology applied to the medical devices concerned is technology intensive and speed of technology innovation is rapid; |
| 2. | Whether the safety and effectiveness of the medical device is improved or is expected to be improved significantly compared with the existing medical devices or treatment methods; |
| 3. | Whether the medical device is used for the diagnosis and treatment of rare and incurable diseases with an economic, social and technological ripple effect; |
| 4. | Other matters deemed necessary by the Minister of Health and Welfare and the Minister of Food and Drug Safety. |
| (3) | The Minister of Food and Drug Safety shall decide whether to designate the medical device or not within 30 days after the date of receiving an application for the designation under paragraph (1). |
| (4) | If the medical devices are designated under paragraph (2) the Minister of Food and Drug Safety shall notify the information of the designated innovative medical devices on the internet website. |
| (5) | The Minister of Food and Drug Safety may cancel the designation of medical device as innovative medical device under paragraph (2) in consultation with the Minister of Health and Welfare if one of the following cases is applicable: Provided, That when subparagraph 1 is applicable, designation shall be canceled and cancellation of the designation shall be notified to the Minister of Health and Welfare: |
| 1. | If the designation of the innovative medical device was done by false or other fraudulent means; |
| 2. | If the medical device is not included in the innovative medical devices group under Article 20 (1) anymore; |
| 3. | If it is recognized that the designation of the innovative medical device does not need to be maintained considering each subparagraph of paragraph (2); |
| (6) | The matters related to application for the designation as innovative medical devices, the designation process and method under paragraphs (1) and (2) and cancellation of designation under paragraph (5) shall be determined by Presidential Decree. |
| Article 22 (Special Cases concerning Permission and Deliberation of Innovative Medical Devices) |
| (1) | Those who intend to manufacture or import an innovative medical device may obtain manufacturing or import permission or manufacturing or import certification (hereinafter referred to as “manufacturing permission, etc.”) under Article 6 (2) and Article 15 (2) of the Medical Devices Act despite Article 6 (1) and Article 15 (1) of the same Act. In such cases, if those who intend to manufacture or import innovative medical devices, they are regarded as the one who obtained manufacturing business permission or import business permission under the Medical Devices Act. |
| (2) | Those who intend to obtain manufacturing permission, etc. regarding innovative medical devices may apply for the review depending on a development stage as stated in the following before applying for manufacturing permission etc. (hereinafter referred to as “phase-specific review”) to the Minister of Food and Drug Safety: |
| 1. | Product design and development examination phase; |
| 2. | Safety and performance examination phase; |
| 3. | Clinical trial protocol examination phase; |
| 4. | Technical document and clinical trial data examination phase. |
| (3) | The Minister of Food and Drug Safety may approve the application under paragraph (2) after discussion on the kinds, scope of data to be submitted, submission schedule and timing of review result notification with applicant if he or she judges that application under paragraph (2) is suitable for the phase-specific review. The same process shall be applied in the case of revising information approved. |
| (4) | If the phase-specific review is completed, the Minister of Food and Drug Safety shall notify the applicants of the phase-specific review results and the review results shall be incorporated in occasions including giving manufacturing permission, etc.: Provided, That this shall not apply to any of the following cases: |
| 1. | If the information on the safety and effectiveness changes after the notification of phase-specific review results; |
| 2. | If the new safety information that could cause risk to human body is presented. |
| (5) | The Minister of Food and Drug Safety may review the application for manufacturing permission, etc. first if the medical devices for which application for manufacturing permission is made is innovative medical devices over the application for manufacturing permission, etc. of medical devices not designated as innovative medical device (hereinafter referred to as “priority review”). |
| (6) | If there is no standards or specification for manufacturing permission, etc. of innovative medical devices or it is not suitable to apply standards or specifications under applicable Acts, the Minister of Food and Drug Safety may provide manufacturing permission, etc. by setting the standards and specification presented by applicants for manufacturing permission, etc. of the concerned innovative medical device as the review criteria if it is deemed reasonable after examining the standards and specifications. |
| (7) | The matters related to application for review under paragraph (2), approval, approval for changes and notification of review results under paragraphs (3) and (4) and scope, method, process and deadline for priority review under paragraph (5) and process and method of setting review criteria under paragraph (6) shall be determined by Ordinance of the Prime Minister. |
| Article 23 (Post-market Surveillance) |
| (1) | If it is deemed necessary to examine the clinical effects and investigate adverse reaction within the scope of manufacturing permission targeting those who obtained manufacturing permission, etc. for the innovative medical devices, the Minister of Food and Drug Safety may order post-market surveillance for the period not exceeding five years: Provided, That this is not applicable if the innovative medical device is subject to re-review under Article 8 of the Medical Devices Act. |
| (2) | If the manufacturer or importer needs to conduct post-market surveillance under paragraph (1), he or she shall conduct surveillance after submit post-market surveillance plan for post-market surveillance as described by Ordinance of the Prime Minister and he or she shall report the current status of surveillance within six months from post-market surveillance to the Minister of Food and Drug Safety; after the completion of the survey, the results shall be submitted. |
| (3) | Matters necessary for the procedure, method, period and documents required for post-market surveillance under paragraphs (1) and (2) shall be determined by Ordinance of the Prime Minister. |
| Article 24 (Special Cases concerning Innovative Medical Devices Software) |
| (1) | The Minister of Food and Drug Safety may exempt the submission of some documents necessary for the manufacturing permission or manufacturing certification by assessing the organization, human resources, product development standards, etc. of the applicant and certifying the applicant as the medical devices software manufacturing company at the quest of those who intend to manufacture medical devices software for designated innovative medical devices (it shall refer to independently developed and manufactured software; hereinafter the same shall apply) according to Article 21 (2). |
| (2) | The Minister of Food and Drug Safety may cancel the certification of those who are certified under paragraph (1) and fall under one of the following categories as stipulated by Ordinance of the Prime Minister: Provided, That certification shall be canceled in case of subparagraph 1 or 2: |
| 1. | If certification is obtained in any false or other wrongful manner; |
| 2. | If the designation of innovative medical devices is canceled under Article 21 (5) and there is no medical devices software designated as an innovative medical devices; |
| 3. | If the party does not meet the certification criteria for medical devices software manufacturing companies. |
| (3) | Medical devices companies certified under paragraph (1) shall collect and assess data regarding post-market safety and effectiveness and comply with requirements in Ordinance of the Prime Minister including the submission of results to the Minister of Food and Drug Safety. |
| (4) | Medical devices manufacturers or importers shall obtain permission on changes or certification on changes under Article 12 (1) of the Medical Devices Act if the major matters that obtain manufacturing permission, etc. and are defined and notified by the Minister of Food and Drug Safety such as intended use, operating principles, and major changes in functions of the medical devices software that is designated as an innovative medical device are changed. |
| (5) | The changes which are not classified as major changes under paragraph (4) shall be notified from manufacturers or importers of medical devices to the Minister of Food and Drug Safety. In such cases, it is regarded as obtaining permission or certification on changes under Article 12 (1) of the Medical Devices Act. |
| (6) | Manufacturers or importers of medical devices shall record and maintain evidence of safety and effectiveness regarding changes under paragraph (5) as stipulated in Ordinance of the Prime Minister. |
| (7) | Those who intend to conduct clinical trial on medical devices software designated as an innovative medical device shall obtain approval from the committee established for the purpose of reviewing clinical trial in designated clinical trial institution under Article 10 (3) of the Medical Devices Act. In such cases, it is regarded as obtaining approval from the Minister of Food and Drug Safety despite Article 10 (1) of the same Act. |
| (8) | If those who intend to conduct clinical trial on medical devices software designated as innovative medical devices do not contact the subject of clinical trial and conduct clinical trial using data such as medical record, they shall comply with the Good Clinical Practice for medical devices software as defined by Ordinance of the Prime Minister. In such cases, Article 10 (4) 1 of the Medical Devices Act is not applicable. |
| (9) | Those who intend to obtain manufacturing permission on medical devices software which is designated as innovative medical device shall secure the facilities and manufacturing and quality control system as stipulated by Ordinance of the Prime Minister and receive review on facilities and manufacturing and quality control system from quality control review institutions under Article 28 of the Medical Devices Act. In this case, if as a result of the review, the system is found to be suitable, it is considered that the company is equipped with facilities and manufacturing and quality control system required under Article 6 (4) of the Medical Devices Act. |
| (10) | The matters necessary for the procedure, method of and standard for certification, permission on changes, reporting of changes, recording and retention related to medical devices software manufacturing companies under paragraphs (1) through (6) shall be determined by Ordinance of the Prime Minister. |
CHAPTER V RESEARCH AND DEVELOPMENT FOR ADVANCEMENT OF MEDICAL DEVICES INDUSTRY
| Article 25 (Implementation of and Support for R&D Projects) |
| (1) | The government may implement projects such as establishment of foundation for medical devices quality evaluation, support for standardization of medical devices criteria and other R&D projects for the advancement of the medical devices industry. |
| (2) | The government may let the relevant organizations and groups conduct projects under paragraph (1) and may support necessary expenses to execute the project. |
| Article 26 (Collection and Sharing of R&D Information) |
| (1) | The Minister of Health and Welfare and the Minister of Food and Drug Safety shall collect and investigate the information regarding domestic and overseas R&D on innovative medical devices such as domestic and overseas R&D trends and market trends and manage and share the collected information in a systematic and comprehensive manner for the purpose of promoting R&D on medical devices efficiently. |
| (2) | The Minister of Health and Welfare and Minister of Food and Drug Safety may designate an organization dedicated to the management of R&D information on innovative medical devices for the purpose of performing tasks under paragraph (1). |
| (3) | The matters related to requirements for the designation and procedure for the organization dedicated to managing R&D information on innovative medical devices under paragraph (2) shall be determined by Presidential Decree. |
| Article 27 (Reward for Medical Devices Companies) |
| (1) | The government may provide reward and support by selecting medical devices companies which contribute to the improvement of public health and development of medical devices industry through development and spread of excellent medical devices. |
| (2) | The matters related to reward and support under paragraph (1) shall be determined by Presidential Decree. |
CHAPTER VI LAYING THE FOUNDATION FOR ADVANCEMENT OF MEDICAL DEVICES INDUSTRY
| Article 28 (Support for Clinical Trial) |
| (1) | The Minister of Health and Welfare may provide expenses necessary for conducting clinical trials to those who intend to conduct clinical trial for medical devices. |
| (2) | The Minister of Food and Drug Safety may provide the following support to make sure that clinical trials on innovative medical devices can be conducted in an efficient and rapid manner: |
| 1. | Preparation of clinical trial protocol; |
| 2. | Harmonization of regulation among countries for international joint clinical trial; |
| 3. | Collection, management and provision of clinical trial information in electronic form. |
| (3) | The details on support under paragraph (1) and procedure and method to support clinical trial under paragraph (2) shall be determined respectively by Ordinance of the Ministry of Health and Welfare and Ordinance of the Prime Minister. |
| Article 29 (Establishment of the Foundation for Safety Management of Innovative Medical Devices and Support for Standardization) |
| (1) | The Minister of Food and Drug Safety may implement the following projects to secure the safety and effectiveness of the innovative medical devices: |
| 1. | Research on the innovative medical devices management system; |
| 2. | Support for the testing and inspection of innovative medical devices; |
| 3. | Support for facilities and manufacturing and quality control system related to innovative medical devices; |
| 4. | Other projects necessary to secure safety and effectiveness. |
| (2) | The Minister of Food and Drug Safety may implement the following projects to standardize the technology and management standards for innovative medical devices: |
| 1. | Enactment, revision, abolition and spread of standards for technology and management of innovative medical devices; |
| 2. | Survey, research and development of domestic and overseas standards related to technology and management of innovative medical devices. |
| (3) | The matters related to procedures and method for the technical support and standardization project for innovative medical devices under paragraphs (1) and (2) shall be determined by Ordinance of the Prime Minister. |
| Article 30 (Support for Promotion of Use of Innovative Medical Devices) |
The Minister of Health and Welfare may support the followings to boost the use of developed innovative medical devices:
| 1. | Project for the pilot operation of medical devices in cooperation with public health institutions; |
| 2. | Assessment of the use of medical devices and performance improvement in cooperation with medical institutions; |
| 3. | Other supports including R&D on the localization of medical devices. |
| Article 31 (Nurturing Professionals) |
| (1) | The government may provide support necessary for nurturing professionals and making them secure qualification required for boosting the medical devices industry and commercialization of innovative medical devices. |
| (2) | The Minister of Health and Welfare and the Minister of Food and Drug Safety may designate appropriate organizations with facilities and human resources such as universities and research institutes as professional development organization for the purpose of nurturing professionals under paragraph (1). |
| (3) | If the professional development agency designated under paragraph (2) falls under one of the following categories, the Minister of Health and Welfare and the Minister of Food and Drug Safety may cancel the designation: Provided, That where subparagraph 1 is applicable, they shall revoke the designation: |
| 1. | If the designation is done by false or by other fraudulent means; |
| 2. | If the agency does not meet the designation criteria for more than three months; |
| 3. | If the agency gives certification to those who did not completed training course. |
| (4) | Matters necessary for designation criteria and operation of a professional development agency under paragraph (2) shall be determined by Presidential Decree. |
| Article 32 (Support for Promotion, Exhibition and Training Center) |
The State or local governments may provide support necessary within the budgetary limit as stipulated by Ordinance of the Ministry of Health and Welfare to those who install and operate an information, exhibition and training center for training people involved in the promotion, sales and medical professionals regarding the medical devices.
| Article 33 (Comprehensive Support Center for Medical Devices Industry) |
| (1) | The Minister of Health and Welfare may designate a public organization prescribed by Presidential Decree as a comprehensive support center for the medical devices industry to support the entry into the market for medical devices companies: |
| 1. | Work to support certification and re-evaluation for innovative medical devices companies under Article 10 (2) and Article 12 (2); |
| 2. | Counseling and advice regarding the procedure to enter into the medical devices market; |
| 3. | Linking government and public organization projects related to the entry into the medical devices market; |
| 4. | Support for the identification and resolution of difficulties related to entry into the medical devices market; |
| 5. | Other projects necessary to support the medical devices industry, determined by Presidential Decree. |
| (2) | The head of the comprehensive support center for the medical devices industry shall obtain approval for a yearly business plan, budget and settlement from the Minister of Health and Welfare and report the business results regularly. |
| (3) | The State may support part or whole expenses necessary for the execution of projects by the comprehensive support center for the medical devices industry. |
| (4) | The Minister of Health and Welfare may request the dispatch of government officials or employees to the central administrative body and public organizations related to the medical devices industry for the efficient execution of works in the comprehensive support center for the medical devices industry, if necessary. |
| (5) | The matters related to the designation and operation of the comprehensive support center for the medical devices industry shall be determined by Presidential Decree. |
| Article 34 (Support for Export) |
The State and local governments may provide support to individuals or groups which promote medical devices or explore the overseas market for medical devices produced by medical devices companies under subparagraph 2 (a) of Article 2 as described in Presidential Decree.
| Article 35 (International Cooperation) |
| (1) | The Minister of Health and Welfare may provide support necessary including the collection and provision of relevant information in case where medical devices companies or relevant groups conduct industrial cooperation activities with overseas institutions or groups. |
| (2) | The Minister of Food and Drug Safety may pursue international cooperation to improve the medical devices management system and harmonization and may provide support for international joint research or international cooperation for medical devices management system in the private sector. |
CHAPTER VII MANAGEMENT AND SUPERVISION
| Article 36 (Investigation and Management) |
| (1) | The Minister of Food and Drug Safety may investigate the manufacturing, import and use of innovative medical devices to secure quality and safety of innovative medical devices. |
| (2) | The Minister of Food and Drug Safety may request the submission of documents or representation of opinion to medical device handlers under Article 2 (3) of the Medical Devices Act, if necessary for the investigation under paragraph (1). In such cases, a person who is requested to provide documents or opinion shall comply with the request unless he or she has a compelling reason not to do so. |
| (3) | The Minister of Food and Drug Safety may order the actions on safety use to those who obtained manufacturing permission on innovative medical devices based on the results of an investigation under paragraph (1), if necessary. |
| (4) | Matters necessary for the scope, method and procedure of an investigation under paragraphs (1) and (2) and matters related to an order under paragraph (3) shall be determined by Ordinance of the Prime Minister. |
| Article 37 (Cancellation of Manufacturing Permission, etc. and Suspension of Business) |
| (1) | The Minister of Food and Drug Safety may cancel manufacturing permission, etc. on the innovative medical devices or order the suspension of manufacturing, import and sales for the maximum one year if those who obtained manufacturing permission, etc. on innovative medical devices fall under one of the following categories: |
| 1. | If a post market surveillance order is not followed in violation of Article 23; |
| 2. | If he or she does not comply with an obligation to collect, assess and submit documents in violation of Article 24 (3); |
| 3. | If he or she reports changes in any false manner in violation of Article 24 (5); |
| 4. | If the evidence is not recorded and kept in violation of Article 24 (6); |
| 5. | If a clinical trial on medical devices is conducted in violation of Article 24 (7) or the Good Clinical Practice is not complied with in violation of Article 24 (8); |
| 6. | If the request for document submission or stating opinion under Article 36 (2) is rejected or avoided without any justifiable reasons; |
| 7. | If he or she does not follow an order such as actions for safe use under Article 36 (3). |
| (2) | The specific criteria regarding the cancellation of manufacturing permission, etc. and suspension of manufacturing, import and sales of products under paragraph (1) shall be determined by Ordinance of the Prime Minister considering the type and significance of violation. |
| Article 38 (Penalty Surcharges) |
| (1) | In case where business suspension shall be ordered under Article 37 (1) and if there is a concern to cause inconvenience for those who use medical devices or to harm public interests, the Minister of Food and Drug Safety may impose a penalty surcharge not exceeding one billion won in lieu of the suspension of business activities, as prescribed by Presidential Decree. |
CHAPTER VIII SUPPLEMENTARY PROVISIONS
| (1) | Those who fall under one of the following categories shall pay fees as determined by Ordinance of the Prime Minister: |
| 1. | Those who intend to go through a phase-specific review under Article 22 (2); |
| 2. | Those who intend to receive a priority review under Article 22 (5). |
| (1) | The Minister of Health and Welfare shall hold a hearing in case where he or she cancels certification of innovative medical devices companies under Article 13. |
| (2) | The Minister of Food and Drug Safety shall hold a hearing in case where he or she suspends part or all of business and cancels manufacturing permission, etc. under Article 37. |
| Article 41 (Delegation and Entrustment of Authority) |
| (1) | The Minister of Health and Welfare may delegate his authority under this Act to the head of a relevant organization, the Special Metropolitan City Mayor, the Metropolitan City Mayor, the Special Self-Governing City Mayor, a Do Governor, the Special Self-Governing Province Governor, and the head of Si/Gun/Gu partially. |
| (2) | The Minister of Health and Welfare may, as prescribed by Presidential Decree, entrust the part of the work related to research and development and market entry under this Act to the Korea Health Industry Development Institute under the Act on the Korea Health Industry Development Institute or organization determined by Presidential Decree. |
| (3) | The Minister of Food and Drug Safety may delegate part of the authority under this Act to the heads of regional offices of the Food and Drug Safety, head of the National Institute of Food and Drug Safety Evaluation, the Special Metropolitan City Mayor, the Metropolitan City Mayor, the Special Self-Governing City Mayor, a Do Governor, the Special Self-Governing Province Governor, the head of Si/Gun/Gu, and the head of public health clinics. |
| (4) | The Minister of Food and Drug Safety may entrust the part of the work related to manufacturing permission, etc. to the National Institute of Medical Device Safety Information according to Article 42 of the Medical Devices Act or organization determined by Presidential Decree. |
| Article 42 (Legal Fiction as Government Officials in Application of Penalty Provisions) |
| Article 43 (Special Cases concerning Medical Devices for Animal) |
| (1) | The matters under this Act which are within the jurisdiction of the Minister of Health and Welfare or the Minister of Food and Drug Safety shall fall under the jurisdiction of the Minister of Agriculture, Food and Rural Affairs if the device is dedicated for animal use. In such cases, the term “Minister of Health and Welfare”or “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 the term “Ordinance of the Ministry of Health and Welfare” or “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 intends to formulate Ordinance of the Ministry of Agriculture, Food and Rural Affairs, he or she shall consult with the Minister of Health and Welfare or the Minister of Food and Drug Safety. |
CHAPTER IX PENALTY PROVISIONS
| Article 44 (Penalty Provisions) |
Those who manufacture and use the certificate or certification mark without getting certification in violation of Article 10 (4) or those who use false certification shall be punished by imprisonment with labor for not more than one year or by a fine not exceeding 10 million won.
| Article 45 (Penalty Provisions) |
Those who fall under one of the following categories shall be punished by a fine not exceeding five million won:
| 1. | Those who do not record and keep evidence documents for changes in violation of Article 24 (6); |
| 2. | Those who refuse to make statement or submit documents under Article 36 (2); |
| 3. | Those who do not follow the order including measures for safety use under Article 36 (3); |
| 4. | Those who violate business suspension order under Article 37 (1). |
| Article 46 (Joint Penalty Provisions) |
If a representative of a corporation, or an agent, employee or other servant of a corporation or an individual commits a violation under Article 44 or Article 45 in conducting the business affairs of the corporation or individual, the corporation or individual shall, in addition to punishing the violator accordingly, be punished by a fine prescribed by the corresponding provision: Provided, That this shall not apply where such corporation or individual has not been negligent in giving due attention and supervision concerning the relevant duties so as to prevent such violation.
| Article 47 (Administrative Fines) |
| (1) | Those who do not submit relevant documents or provide false document under Article 14 (1) without any justifiable reason shall be subject to a fine not exceeding three million won. |
| (2) | An administrative fine under paragraph (1) shall be imposed and collected by the Minister of Health and Welfare as determined by Presidential Decree. |
ADDENDA <No. 16405, Apr. 30, 2019>
Article 1 (Enforcement date)
This Act shall enter into force one year after the date of the promulgation.
Article 2 (Validity)
Articles 18 and 19 shall remain in force for 10 years from the effective date of this Act. Article 3 (Special Cases concerning Expiration of Validity Period)
| (1) | For research facilities under construction at the expiration of the validity period under Article 18, if the facilities obtained construction permission or reported construction under Article 18, Article 18 shall be applicable after the expiration of the validity period. |
| (2) | For research facilities subject to exemption of contribution under Article 19 at the expiration of the validity period under Article 19, the same Article shall be applicable after the expiration. |
Article 4 Omitted.