ACT ON NURTURING MEDICAL DEVICES INDUSTRY AND SUPPORTING INNOVATIVE MEDICAL DEVICES

CHAPTER I GENERAL PROVISIONS

Article 1(Purpose) #

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.

Article 2(Definitions) #

The terms used in this Act are defined as follows: <Amended on Jan. 9, 2024>

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;

c. A company specialized in research and development of medical devices among venture companies defined in Article 2-2 of the Special Act on the Promotion of Venture Businesses;

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 prescribed by the Presidential Decree;

b. A foreign-invested company, which has invested in the research and development of medical devices more than the amount prescribed by Presidential Decree in Korea or a foreign-invested medical devices company in accordance with Article 2 (1) 6 of the Foreign Investment Promotion Act;

ACT ON NURTURING MEDICAL DEVICES INDUSTRY AND SUPPORTING INNOVATIVE MEDICAL DEVICES

Article 1(Purpose) #

Article 2(Definitions) #

Article 3(Responsibilities of the State and local governments) #

Article 4(Responsibilities of medical devices companies) #

Article 5(Relationship with other Acts) #

Article 6(Establishment of master plan) #

Article 7(Establishment of implementation plan) #

Article 8(Medical Devices Industry Promotion and Support Committee) #

Article 9(Survey on actual situation) #

Article 10(Certification of innovative medical devices companies) #

Article 11(Succession of status) #

Article 12(Validity period of certification) #

Article 13(Cancellation of certification) #

Article 14(Provision of data) #

Article 15(Classification of innovative medical devices companies by type) #

Article 16(Preferential treatment regarding national research and development projects) #

Article 17(Special cases concerning taxation) #

Article 18(Special cases concerning research facility construction) #

Article 19(Exemption of various kinds of charges) #

Article 20(Designation of innovative medical devices group) #

Article 21(Designation and cancellation of innovative medical devices) #

Article 22(Special cases concerning permission and deliberation of innovative medical devices) #

Article 23(Post-market surveillance) #

Article 24(Special cases concerning innovative medical devices software) #

Article 25(Implementation of and support for research and development projects) #

Article 26(Collection and sharing of research and development information) #

Article 27(Reward for medical devices companies) #

Article 28(Support for clinical trial) #

Article 29(Establishment of the foundation for safety management of innovative medical devices and support for standardization) #

Article 30(Support for promotion of use of innovative medical devices) #

Article 31(Nurturing professionals) #

Article 32(Support for promotion, exhibition and training center) #

Article 33(Comprehensive support center for medical devices industry) #

Article 34(Support for export) #

Article 35(International cooperation) #

Article 36(Investigation and management) #

Article 37(Cancellation of manufacturing permission and suspension of business) #

Article 38(Penalty surcharges) #

Article 39(Fees) #

Article 40(Hearing) #

Article 41(Delegation and entrustment of authority) #

Article 42(Legal fiction as public officials for purposes of applying penalty provisions) #

Article 43(Special cases concerning medical devices for animal) #

Article 44(Penalty provisions) #

Article 45(Penalty provisions) #

Article 46(Joint penalty provisions) #

Article 47(Administrative fines) #