CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to develop high-tech medical complexes to the global hub for research and development of medical services and contribute to the growth of the domestic medical industry by facilitating the active research and development of medical services and the commercialization of achievements from research with mutual cooperation between enterprises, universities, research institutes, and medical institutions through promoting the development of the high-tech medical complexes. <Amended on Apr. 30, 2019>
The terms used in this Act are defined as follows: <Amended on Jan. 18, 2010; Jan. 6, 2016>
| 1. | The term "high-tech medical complex" means a complex designated and publicly notified by the Minister of Health and Welfare pursuant to Article 6 in order to facilitate the active research and development of medical services and the commercialization of achievements from research; |
| 2. | The term "medicine" means medicine as defined in the Pharmaceutical Affairs Act; |
| 3. | The term "medical appliances" means medical appliances as defined in the Medical Devices Act; |
| 4. | The term "technology for health and medical services" means the health and medical service technology as defined in Article 2 (1) 1 and 3 of the Health and Medical Service Technology Promotion Act; |
| 5. | The term "research and development of medical services" means the research and development of medicine, medical appliances, or technology for health and medical services, the clinical trials for such research and development, or the manufacture of medicines or medical appliances related to research and development; |
| 6. | The term "research and development institute of medical services" means an institution falling under any of the following items and equipped with researchers and facilities that meet the standards prescribed by Presidential Decree for the research and development of medical services: |
| (a) | An institution established for the purposes of research and development of medical services; |
| (b) | Any of the following institutions that has installed and operates a department responsible for the research and development of medical services: |
| (i) | A medical institution; |
| (ii) | A university or college under Article 2 of the Higher Education Act; |
| (iii) | A research institute; |
| (iv) | A government-funded institution or similar; |
| 7. | Deleted; <Oct. 24, 2017> |
| 8. | The term "resident research and development institute of medical services" means a research and development institute of medical services that has moved into a high-tech medical complex with the approval for move-in under Article 31. |
| Article 3 (Relationship to other statutes or regulations) |
| (1) | Chapter IV (Article 20 through 26) of this Act that provides for special cases in order to relax regulation shall take precedence over other statutes or regulations; provided, if any other Act or subordinate statute has a provision that relaxes regulation more than the special cases for regulation under this Act, the provisions of such statutes or regulations shall apply. |
| (2) | If any person who is otherwise entitled to the application of the special cases for regulation under Article 21 (2), 23 (2), or 24 (2) fails to comply with any provision of this Act, such person shall be governed by each corresponding statute or regulation. |
CHAPTER II DEVELOPMENT OF HIGH-TECH MEDICAL COMPLEXES
| Article 4 (Formulation of plan for development of high-tech medical complexes) |
| (1) | The Minister of Health and Welfare shall, after hearing the opinions of the heads of relevant central administrative agencies and the head of the local government having jurisdiction over the area where a high-tech medical complex is to be established, formulate and finalize a development plan for the high-tech medical complex (hereinafter referred to as "development plan"); and, if necessary, may consult the Council of High-Tech Medical Complexes under Article 27 before finalizing the development plan. The same shall apply to any modification of the development plan. <Amended on Dec. 31 2008; Jan. 18 2010; Jan. 9 2024> |
| (2) | The Minister of Health and Welfare shall take into consideration the balanced development of national land in formulating a development plan. <Amended on Dec. 31, 2008; Jan. 18, 2010> |
| (3) | Each development plan shall include the following: <Amended on Oct. 24, 2017> |
| 1. | Matters concerning the site selection, such as the location and area of the relevant high-tech medical complex; |
| 2. | Purposes of the development of the high-tech medical complex; |
| 3. | A layout plan for facilities, etc. of the high-tech medical complex; |
| 4. | A plan for the establishment of a medical innovation foundation under Article 11 and for attracting of research and development institutes of medical services; |
| 5. | A plan for the procurement of financial resources; |
| 6. | The period and an annual plan for the promotion of the project; |
| 7. | Other matters specified by Presidential Decree as necessary for the development of, and the support to, the high-tech medical complex. |
| Article 5 (Site selection for high-tech medical complexes) |
| (1) | To select the site of a high-tech medical complex, the Minister of Health and Welfare shall designate an area that excels in meeting the site selection criteria from among all or part of any of the following zones (hereinafter referred to as "complex, etc."): <Amended on Dec. 31, 2008; Jan. 30, 2009; Jan. 18, 2010; Aug. 4, 2011; Jan. 26, 2012; Dec. 26, 2017> |
| 1. | An industrial complex prescribed in subparagraph 8 of Article 2 of the Industrial Sites and Development Act; |
| 2. | A free economic zone under subparagraph 1 of Article 2 of the Special Act on Designation and Management of Free Economic Zones; |
| 3. | A special research and development zone under subparagraph 1 of Article 2 of the Special Act on Promotion of Special Research and Development Zone; |
| 4. | An urban planning area under Article 2 (1) 1 of the Urban Development Act; |
| 5. | An industrial technology complex under Article 2 of the Act on Special Cases concerning Support for Technoparks; |
| 6. | A district for the planned development of an innovation city under subparagraph 4 of Article 2 of the Special Act on the Construction and Development of Innovation Cities; |
| 7. | An area for the development of an enterprise city under subparagraph 2 of Article 2 of the Special Act on the Development of Enterprise Cities; |
| 8. | Any other area specified by Presidential Decree as an area designated and developed pursuant to any other Act, taking into consideration the feasibility of development to a high-tech medical complex. |
| (2) | The site selection criteria to be applied where the Minister of Health and Welfare intends to designate the site of a high-tech medical complex under paragraph (1) shall be as follows: <Amended on Dec. 31 2008; Jan. 18 2010> |
| 1. | The feasibility of invitation and settlement of outstanding domestic and foreign researchers and research and development institutes of medical services; |
| 2. | The level of clustering and connectivity of outstanding research and development institutes of medical services; |
| 3. | The levels of clustering of outstanding medical institutions; |
| 4. | The ease in securing the building site for the high-tech medical complex; |
| 5. | Details of support from the competent local government in finance, taxation, and other aspects; |
| 6. | Other matters specified by Presidential Decree as necessary for the development and fostering of the high-tech medical complex, such as the balanced development of national land. |
| (3) | Standards for outstanding researchers, research and development institutes of medical services, and medical institutions, and detailed standards concerning the feasibility of invitation and settlement of such researchers, institutes, and institutions, the level of clustering and connectivity of outstanding research and development institutes of medical services under paragraph (2), and other relevant matters shall be prescribed by Presidential Decree. |
| (4) | Notwithstanding paragraph (1), if the Minister of Health and Welfare deems that an area other than a complex, etc. is superior in meeting the site selection criteria under the subparagraphs of paragraph (2), the Minister may designate such area as the site of a high-tech medical complex. In such cases, if the Minister of Health and Welfare may consult the Council of High-Tech Medical Complexes, if deemed necessary, before selecting the site. <Amended on Dec. 31 2008; Jan. 18 2010; Jan. 9 2024> |
| Article 6 (Designation of high-tech medical complexes) |
| (1) | The Minister of Health and Welfare shall, when the site for a high-tech medical complex is selected pursuant to Article 5, designate and publicly notify it as a high-tech medical complex, as prescribed by Presidential Decree, and also notify heads of appropriate central administrative agencies and the head of the competent metropolitan/provincial local government thereof without delay. <Amended on Jan. 18, 2010> |
| (2) | The head of the competent metropolitan/provincial local government shall, upon receiving a notice under paragraph (1), make the details of the notice available to the general public for inspection for at least 14 days. |
| Article 7 (Development of high-tech medical complexes) |
| (1) | In cases where a complex, etc. under Article 5 (1) is designated and publicly notified as a high-tech medical complex, the development of such high-tech medical complex shall proceed in accordance with the procedure provided by the Act on which the complex, etc. is based. |
| (2) | In cases where a site selected pursuant to Article 5 (4) is designated and publicly notified as a high-tech medical complex pursuant to Article 6 (1), the Minister of Land, Infrastructure and Transport shall designate and develop it as a national industrial complex pursuant to the Industrial Sites and Development Act. In such cases, the designation of such national industrial complex, the cancellation of such designation, and the development of such complex shall proceed in accordance with the procedures provided by the aforesaid Act, but the case is deemed to have undergone deliberation by the committee for the deliberation on the policy on industrial sites under the procedure. <Amended on Mar. 23, 2013> |
| (3) | In designating a high-tech medical complex as a national industrial complex pursuant to paragraph (2), the Minister of Land, Infrastructure and Transport may designate it as a national industrial complex, even if it fails to meet the standards for the area eligible for the designation of an industrial complex and the ratio of unsold parcels of land, notwithstanding Article 8-2 of the Industrial Sites and Development Act. <Amended on Mar. 23, 2013> |
| Article 8 (Cancellation of designation of high-tech medical complexes) |
| (1) | If it is deemed that the purposes of designation of a high-tech medical complex have been achieved or that it is impossible to achieve the purposes of designation of such complex, the Minister of Health and Welfare may cancel the designation of the high-tech medical complex. <Amended on Jan. 18, 2010> |
| (2) | Article 6 shall apply mutatis mutandis to the procedure for the cancellation of designation of a high-tech medical complex pursuant to paragraph (1). |
| Article 9 (Preferential support for infrastructure) |
The State and each local government shall provide preferential support for the installation of infrastructure, such as roads and water supply systems, in order to smoothly develop high-tech medical complexes.
| Article 10 (Formulation of comprehensive plan for high-tech medical complexes) |
| (1) | The Minister of Science and ICT, the Minister of Trade, Industry and Resources, the Minister of Food and Drug Safety, and the head of the competent metropolitan/provincial local government (hereafter in this Article referred to as the "head of the operating agency") shall submit to the Minister of Health and Welfare a plan for the promotion of matters under their respective jurisdiction for the fostering of high-tech medical complexes every 5 years, as prescribed by Presidential Decree. <Amended on Dec. 31, 2008; Jan. 18, 2010; Mar. 23, 2013; Jul. 26, 2017; Oct. 24, 2017; Oct. 1, 2025> |
| (2) | The Minister of Health and Welfare shall integrate the promotion plans submitted pursuant to paragraph (1) and formulate a comprehensive plan for fostering high-tech medical complexes every five years (hereinafter referred to as "comprehensive plan"), but may adjust the timetable for the promotion and matters overlapping or conflicting with one another in the promotion plans submitted pursuant to paragraph (1), if necessary for the smooth execution of the affairs related to high-tech medical complexes, subject to consultation with the head of the competent operating agency. <Amended on Dec. 31, 2008; Jan. 18, 2010; Oct. 24, 2017> |
| (3) | If necessary, the Minister of Health and Welfare may consult the Council of High-Tech Medical Complexes before finalizing the comprehensive plan formulated under paragraph (2), and, once the comprehensive plan is finalized, shall notify the head of the operating institution thereof. The same shall apply to any modification of the comprehensive plan. <Added on Dec. 31 2008; Jan. 18 2010; Jan. 9 2024> |
| (4) | The comprehensive plan shall include the following: <Amended on Dec. 31, 2008; Oct. 24, 2017> |
| 1. | Matters concerning the establishment of the basic directions and objectives of fostering high-tech medical complexes; |
| 2. | Matters concerning the operation of, and support for, a medical innovation foundation under Article 11; |
| 3. | Matters concerning support to resident research and development institutes of medical services; |
| 4. | Matters concerning the stimulation of mutual exchanges and cooperation between resident research and development institutes of medical services; |
| 5. | Matters concerning the stimulation of cooperation between medical innovation foundations, resident research and development institutes of medical services, and domestic and foreign research and development institutes of medical services; |
| 6. | Matters concerning the creation of conditions for the invitation and settlement of outstanding domestic and foreign researchers and research and development institutes of medical services; |
| 7. | Matters concerning the utilization and dissemination of achievements from the operation of high-tech medical complexes; |
| 8. | Other matters specified by Presidential Decree as necessary for fostering high-tech medical complexes. |
| (5) | The head of each operating agency shall formulate and promote a detailed implementation plan for each year based on the comprehensive plan notified pursuant to paragraph (3). <Amended on Dec. 31, 2008> |
CHAPTER III SUPPORT TO RESIDENT INSTITUTIONS IN HIGH-TECH MEDICAL COMPLEXES
| Article 11 (Establishment of and support for foundations) |
| (1) | The local government having jurisdiction over the address of a high-tech medical complex, research and development institutes of medical services, and other contributing institutions may jointly make contributions to establish a medical innovation foundation (hereinafter referred to as "foundation"). |
| (2) | Each foundation under paragraph (1) shall be established with permission of the competent authorities pursuant to Article 32 of the Civil Act. |
| (3) | The articles of association of a foundation shall include the following: <Added on Dec. 11, 2018> |
| 3. | Location of the main office; |
| 4. | Matters regarding assets; |
| 5. | Matters regarding executive officers and employees; |
| 6. | Operation of the board of directors; |
| 7. | Scope, details, and execution of its business; |
| 9. | Methods of making public announcement; |
| 10. | Amendments to the articles of association; |
| 11. | Other important matters regarding the operation of the foundation. |
| (4) | Where a foundation intends to amend any matter stated in its articles of association, it shall obtain authorization therefor from the Minister of Health and Welfare. <Added on Dec. 11, 2018> |
| (5) | A foundation under paragraph (1) shall perform the following duties: <Amended on Dec. 11, 2018> |
| 1. | Improvement in and support for research performance of high-tech medical complexes; |
| 2. | Support for development and commercialization of products by resident research and development institutes of medical services; |
| 3. | Support for attracting, fostering, and utilizing human resources specializing in research and development of medical services; |
| 4. | Cooperation with domestic and foreign research institutes, academia, and the industry; |
| 5. | Securing base technologies through joint research with research and development institutes of medical services, etc.; |
| 6. | Business designated or entrusted by the State and local governments; |
| 7. | Other business prescribed by Presidential Decree to support duties of high-tech medical complexes. |
| (6) | A foundation may establish the following centers for supporting research and development of medical services to perform the duties referred to in paragraph (5): <Amended on Dec. 11, 2018> |
| 1. | A center for supporting research and development of medical services regarding medicine: A center to support duties related to research and development of research and development institutes of medical services established to research and develop medicine and to jointly research and develop medicine with research and development institutes of medical services; |
| 2. | A center for supporting research and development of medical services regarding medical appliances: A center to support duties related to research and development of research and development institutes of medical services established to research and develop medical appliances or to jointly research and develop medical appliances with research and development institutes of medical services; |
| 3. | A center for raising and managing laboratory animals; |
| 4. | A center for producing medicine or medical appliances related to research and development of medical services or for providing facilities to produce such medicine or medical appliances; |
| 5. | Other centers prescribed by Presidential Decree, such as a center for managing resources related to research and development of medical services. |
| (7) | The State and each local government may subsidize expenses incurred in establishment, operation, etc. of a foundation, within the budget. <Amended on Dec. 11, 2018> |
| (8) | Except as provided in this Act and the Act on the Management of Public Institutions, the provisions of the Civil Act governing incorporated foundations shall apply mutatis mutandis to foundations. <Amended on Dec. 11, 2018> |
| (9) | The State and each local government may provide support for the organization or establishment of any of the following investment associations or companies, the main purpose of which is investment in resident research and development institutes of medical services: <Amended on Dec. 11, 2018; Feb. 11, 2020; Apr. 20, 2021> |
| 1. | A venture investment association under subparagraph 11 of Article 2 of the Venture Investment Promotion Act; |
| 2. | A new technology venture investment association under subparagraph 14-5 of Article 2 of the Specialized Credit Finance Business Act; |
| 3. | An institutional private equity fund under Article 9 (19) 1 of the Financial Investment Services and Capital Markets Act. |
[This Article Wholly Amended on Oct. 24, 2017]
| Article 12 (Support to joint research and development projects) |
| (1) | Any foundation and any research and development institute of medical services may jointly undertake a project for research and development of medical services (hereinafter referred to as "joint research and development project") for a specific period, utilizing the facilities and human resources of the foundation. <Amended on Oct. 24, 2017> |
| (2) | The State and each local government may contribute funds for research and development to support any joint research and development project. <Amended on Dec. 29, 2015> |
| (3) | Any foundation may treat an enterprise preferentially in distributing intellectual property or any similar rights arising from any joint research and development project under paragraph (1) or in transferring technology pursuant to subparagraph 2 of Article 2 of the Technology Transfer and Commercialization Promotion Act. <Amended on Oct. 24, 2017> |
| Article 13 (Grant of loans) |
| (1) | The Minister of SMEs and Startups may have the Korea SMEs and Startups Agency provide, as a loan, the Fund for the Establishment and Promotion of SMEs and Startups under Article 63 of the Small and Medium Enterprises Promotion Act, for the research and development of medical services conducted by any foundation or any research and development institute of medical services in a high-tech medical complex. <Amended on May 21, 2009; Mar. 23, 2013; Oct. 24, 2017; Apr. 30, 2019> |
| (2) | The Minister of SMEs and Startups may, if any person to whom a loan was granted pursuant to paragraph (1) fails in the relevant project and is unable to repay the loan granted, abate or exempt the person's obligation to repay the principal and interest thereon, fully or partially, and may allow the person to repay the loan with part of his or her earnings, if the person succeeds in the relevant project. In such cases, the portion of the repayment excluding an amount equivalent to the principal and interest thereon shall not be deemed the assumed interest under Article 4 of the Interest Limitation Act. <Amended on Mar. 23, 2013; Apr. 30, 2019> |
| (3) | Matters necessary for the standard of success and failure under paragraph (2), the persons eligible for loans, the terms and conditions of loans, the procedure for loans, the repayment method, and other relevant matters shall be prescribed by Presidential Decree. |
| Article 14 (Support by taxation) |
The State and each local government may support foundations and resident research and development institutes of medical services with abatement of, or exemption from, national taxes or local taxes, as provided by tax laws. <Amended on Oct. 24, 2017>
| Article 15 (Support in move-in) |
The competent local government may support any person who desires to move into a high-tech medical complex for the purpose of research and development of medical services with abatement of, or exemption from, rent or similar for land, building, or other property.
| Article 16 (Support by installation of ancillary facilities) |
The State and each local government may subsidize the funds that foundations and resident research and development institutes of medical services need for the installation and operation of various kinds of ancillary facilities, such as accommodations, convenience facilities, child-care facilities, and welfare facilities. <Amended on Oct. 24, 2017>
| Article 17 (Payment of employment subsidies) |
The State and each local government may grant employment subsidies and subsidies for education and training to foundations and resident research and development institutes of medical services. <Amended on Oct. 24, 2017>
| Article 18 (Special cases for commercial use, loan, and sale of State-owned or public property) |
| (1) | The State and each local government may convey any State or public property owned by the State or the local government, by permission for commercial use, loan, or sale under a negotiated contract, to any foundation or any resident research and development institute of medical services, notwithstanding the State Property Act, the Public Property and Commodity Management Act, or any other statute or regulation. <Amended on Oct. 24, 2017> |
| (2) | Where any State-owned or public property is conveyed by permission for commercial use or loan pursuant to paragraph (1), the term of such conveyance may be set to within the maximum of 20 years, notwithstanding Article 27 (1) or 36 (1) of the State Property Act and Article 21 (1) or 31 (1) of the Public Property and Commodity Management Act. In such case, the term of conveyance may be renewed, and each renewed term shall not exceed 20 years. |
| (3) | Where any parcel of land owned by the State or a local government is conveyed by permission for commercial use or loan pursuant to paragraph (1), erecting a permanent structure on the land may be permitted, notwithstanding Article 24 (3) of the State Property Act and Article 13 of the Public Property and Commodity Management Act. In such case, taking into account the kind, etc. of such structure, the condition that such structure shall be donated to the State or the local government, or the parcel of land shall be returned with its original state restored, at the end of the term, may be attached thereto. |
| (4) | The standards for the calculation of charge or rent for commercial use or loan of the State-owned or public property conveyed by permission for commercial use or loan pursuant to paragraph (1) shall be prescribed by Presidential Decree, notwithstanding Article 25 (1) or 38 of the State Property Act and Article 22 or 32 of the Public Property and Commodity Management Act. |
| (5) | If a purchaser is deemed to have difficulties in paying a purchase price in a lump sum when any State-owned or public property is sold to a foundation or a resident research and development institute of medical services under paragraph (1), the deadline for payment may be deferred, or payment in installments may be permitted, as prescribed by Presidential Decree, notwithstanding Article 40 (1) of the State Property Act and Article 37 (1) of the Public Property and Commodity Management Act. <Amended on Oct. 24, 2017> |
| Article 19 (Allowance of voluntary suspension of employment or currently holding office by researchers of national or public research institutes) |
| (1) | Any researcher of a national or public research institute who is not a public official (including teaching staff members and researchers under Article 15 of the Korea Advanced Institute of Science and Technology Act, Article 14 of the Gwangju Institute of Science and Technology Act, Article 12-3 of the Daegu Gyeongbuk Institute of Science and Technology Act, and Article 8 of the Ulsan National Institute of Science and Technology Act; hereinafter the same shall apply) may voluntarily suspend his or her employment or concurrently hold an office in order to work, as an executive or employee, for a foundation or a resident research and development institute of medical services. <Amended on Oct. 24, 2017> |
| (2) | The period of the voluntary suspension of employment under paragraph (1) shall not exceed three years. |
| (3) | Where researchers of a national or public research institute voluntarily suspends their employment for at least six months pursuant to paragraph (1), the relevant national or public research institute is deemed to have an additional prescribed number of researchers corresponding to the number of the researchers voluntarily suspending their employment. |
CHAPTER IV MATTERS CONCERNING SPECIAL CASES FOR REGULATION ON HIGH-TECH MEDICAL COMPLEXES
| Article 20 (Special cases for the Immigration Act) |
Notwithstanding Articles 8 and 10 of the Immigration Act, the procedure for issuance of visa to foreigners working for a foundation or a resident research and development institute of medical services and the maximum period of sojourn for each status of sojourn that may be issued on each occasion may be prescribed differently by Presidential Decree. <Amended on Oct. 24, 2017>
| Article 21 (Special cases concerning the Medical Service Act) |
| (1) | Notwithstanding Article 5 and 27 of the Medical Service Act, any foreign medical doctor or dentist who meets the standards prescribed by the Minister of Health and Welfare may conduct medical activities for the purposes of research and development of medical services in a medical institution designated by the Minister of Health and Welfare in a high-tech medical complex. <Amended on Jan. 18, 2010> |
| (2) | Any person who desires to conduct medical activities pursuant to paragraph (1) shall obtain approval of the Minister of Health and Welfare. <Amended on Jan. 18, 2010> |
| (3) | Any person who conducts medical activities under paragraphs (1) and (2) is deemed a medical doctor or a dentist under the Medical Service Act, and the Minister of Health and Welfare may cancel the approval, if the person commits an offense specified in Article 65 or 66 of the Medical Service Act. <Amended on Jan. 18, 2010> |
| Article 22 (Special cases concerning the National Health Insurance Act) |
| (1) | Notwithstanding Article 41 of the National Health Insurance Act, the medicines, medical appliances, or medical technology applied to any person under clinical trials conducted for research and development of medical services by a medical institution designated by the Minister of Health and Welfare in a high-tech medical complex are deemed medical care benefits. <Amended on Jan. 18, 2010; Dec. 31, 2011> |
| (2) | The criteria for medical care benefits, such as the persons eligible for medical care benefits under paragraph (1), the method, scope, and maximum of, and the procedure for, such medical care benefits, shall be prescribed by Decree of the Ministry of Health and Welfare. <Amended on Jan. 18, 2010> |
| Article 23 (Special cases concerning the Pharmaceutical Affairs Act) |
| (1) | Any resident research and development institute of medical services that desires to manufacture any medicine developed as a result of its research shall obtain item permission from the Minister of Food and Drug Safety, as prescribed by Prime Ministerial Decree. In such case, the Minister of Food and Drug Safety may grant item permission to any resident research and development institute of medical services that has no permission for manufacturing business under Article 31 of the Pharmaceutical Affairs Act or that fails to meet the standards for facilities under the aforesaid Act, and the resident research and development institute of medical services that has obtained item permission from the Minister of Food and Drug Safety shall be deemed to obtain permission for manufacturing business under the Pharmaceutical Affairs Act. <Amended on Jan. 18, 2010; Mar. 23, 2013; Oct. 24, 2017> |
| (2) | If any foundation or any resident research and development institute of medical services obtains approval for import from the Minister of Food and Drug Safety with regard to the item, quantity, etc. of any medicine imported from a country designated by the Minister of Food and Drug Safety in order to use it for the purposes of research and development of medical services, such institution or institute is deemed to have obtained permission for import, or have filed a report on import, in accordance with Article 42 of the Pharmaceutical Affairs Act. <Amended on Mar. 23, 2013; Oct. 24, 2017> |
| (3) | Where any resident research and development institute of medical services files an application for permission for a manufactured or imported item of medicine with the Minister of Food and Drug Safety under paragraph (1) or Article 31 (12) or 42 (5) of the Pharmaceutical Affairs Act, it may prepare such application in a foreign language only for the research and development of medical services within the relevant high-tech medical complex, as prescribed by the Minister of Food and Drug Safety. <Amended on Mar. 30, 2011; Mar. 23, 2013; Jan. 15, 2019> |
| (4) | The Minister of Food and Drug Safety may apply the standards prescribed by international organizations, etc. specified by the Minister of Health and Welfare as the standards for permission for a manufactured or imported item of medicine granted to any resident research and development institute of medical services or any foundation under paragraph (1) or Article 31 (12) or 42 (5) of the Pharmaceutical Affairs Act. <Amended on Jan. 18, 2010; Mar. 30, 2011; Mar. 23, 2013; Oct. 24, 2017; Jan. 15, 2019> |
| (5) | Matters necessary for item permission and the standards and procedure for approval for import under paragraphs (1), (2), and (4) and other relevant matters shall be prescribed by Decree of the Ministry of Health and Welfare. <Amended on Jan. 18, 2010> |
| Article 24 (Special cases concerning the Medical Devices Act) |
| (1) | Any resident research and development institute of medical services that desires to manufacture a medical appliance developed as a result of its research (excluding those subject to a manufacturing report as specified by Prime Ministerial Decree pursuant to Article 6 (8) of the Medical Devices Act) shall obtain a manufacturing permit from the Minister of Food and Drug Safety, as prescribed by Prime Ministerial Decree. In such case, the Minister of Food and Drug Safety may grant a manufacturing permit to a resident research and development institute of medical services that has not obtained a permit for the manufacturing business under Article 6 of the Medical Devices Act or that fails to meet the standards for facilities, etc. set forth in the aforesaid Act, and a resident research and development institute of medical services that has obtained a manufacturing permit from the Minister of Food and Drug Safety is deemed to obtain a permit for the manufacturing business under the Medical Devices Act. <Amended on Jan. 18, 2010; Apr. 7, 2011; Mar. 23, 2013; Oct. 24, 2017> |
| (2) | If any foundation or any resident research and development institute of medical services obtains importation approval from the Minister of Food and Drug Safety with regard to the item, quantity, etc. of any medical appliance imported from a country designated by the Minister of Food and Drug Safety in order to use it for the purposes of research and development of medical services, such foundation or institute is deemed to have obtained an importation business permit or importation permit by item category or item, or have filed an importation report, in accordance with Article 15 of the Medical Devices Act. <Amended on Apr. 7, 2011; Mar. 23, 2013; Oct. 24, 2017> |
| (3) | Where any resident research and development institute of medical services files an application for a manufacturing permit or importation permit for any medical appliance with the Minister of Food and Drug Safety in accordance with paragraph (1) or Article 6 (7) or 15 (6) of the Pharmaceutical Affairs Act, it may prepare such application in a foreign language only for the research and development of medical services within the relevant high-tech medical complex, as prescribed by the Minister of Food and Drug Safety. <Amended on Apr. 7, 2011; Mar. 23, 2013> |
| (4) | The Minister of Food and Drug Safety may apply the standards prescribed by international organizations, etc. specified by the Minister of Health and Welfare with regard to the standards, etc. for granting a manufacturing permit or importation permit for medical appliances to any resident research and development institute of medical services or any foundation pursuant to paragraph (1) or Article 6 (7) or 15 of the Medical Devices Act. <Amended on Jan. 18, 2010; Apr. 7, 2011; Mar. 23, 2013; Oct. 24, 2017> |
| (5) | Matters necessary for the standards and procedures for the manufacturing permits or importation approvals under paragraphs (1), (2), and (4) and other relevant matters shall be prescribed by Decree of the Ministry of Health and Welfare. <Amended on Jan. 18, 2010; Apr. 7, 2011> |
| Article 25 (Special cases concerning the Bioethics and Safety Act) |
| (1) | The National Bioethics Committee under the Bioethics and Safety Act shall install a sub-committee for high-tech medical complexes to have the sub-committee deliberate on the matters specified by Decree of the Ministry of Health and Welfare among the matters concerning the bioethics and safety under the aforesaid Act within high-tech medical complexes. <Amended on Jan. 18, 2010> |
| (2) | The matters deliberated by the sub-committee for high-tech medical complexes under paragraph (1) are deemed to have been deliberated by the National Bioethics Committee under the Bioethics and Safety Act. |
| (3) | Notwithstanding Article 10 of the Bioethics and Safety Act, resident research and development institutes of medical services may jointly organize an institutional bioethics committee. <Amended on Feb. 1, 2012> |
| (4) | The organization and operation of the sub-committee for high-tech medical complexes and the institutional bioethics committee under paragraphs (1) and (3) and other necessary matters shall be prescribed by Presidential Decree. <Amended on Feb. 1, 2012> |
| Article 26 (Special cases for the Patent Act) |
Notwithstanding Article 61 of the Patent Act, the Minister of the Korean Intellectual Property Office may authorize examiners to preferentially examine patent applications filed by any resident research and development institute of medical services in connection with research and development of medical services within the relevant high-tech medical complex prior to other patent applications. <Amended on Oct. 1, 2025>
| Article 26-2 (Installation of production facilities for resident research and development institute of medical services) |
| (1) | A resident research and development institute of medical services may install small- scale production facilities prescribed by Presidential Decree for drugs or medical devices researched and developed within a high-tech medical complex; provided, a resident research and development institute of medical services whose headquarters is located within the high-tech medical complex may also install the production facilities referred to in the main clause for drugs or medical devices researched and developed outside the complex. <Amended on Feb. 6, 2024> |
| (2) | A person who intends to establish a production facility under paragraph (1) shall obtain approval from the Minister of Health and Welfare, and the same shall apply to any change to important matters prescribed by Presidential Decree among the approved matters. |
[This Article Added on Jan. 6, 2016]
CHAPTER V COUNCIL OF HIGH-TECH MEDICAL COMPLEXES
| Article 27 (Establishment and operation of Council of High-Tech Medical Complexes) |
The Minister of Health and Welfare may establish and operate a Council of High-Tech Medical Complexes, if necessary to consult on the following matters regarding the promotion of advanced medical complexes: <Amended on Oct. 24 2017; Apr. 30 2019; Jan. 9 2024>
| 1. | Matters concerning the basic policy for fostering high-tech medical complexes; |
| 2. | Matters concerning the formulation of, and the revision to, the development plan, the designation of high-tech medical complexes, and the cancellation of such designation; |
| 3. | Matters concerning the formulation of the comprehensive plan and the evaluation of achievements thereof; |
| 4. | Matters concerning the evaluation of results of joint research projects and the evaluation of achievements from the operation of foundations; |
| 5. | Matters concerning the invitation of outstanding domestic and foreign researchers and research and development institutes of medical services; |
| 6. | Matters concerning the financial support for, and special cases for regulation on, fostering high-tech medical complexes; |
| 7. | Matters concerning the adjustment of opinions of the heads of appropriate administrative agencies and the head of the competent metropolitan/provincial local government on the operation of, and the support to, a high-tech medical complex; |
| 8. | Matters concerning the evaluation of achievements in the financial support and the application of special cases for regulation; |
| 9. | Other matters specified as matters subject to consultation by the Council of High-Tech Medical Complexes and matters necessary for fostering high-tech medical complexes, which are referred to a meeting by the chairperson; |
[Title Amended on Jan. 9, 2024]
| Article 28 (Composition and operation) |
| (1) | The Minister of Health and Welfare shall serve as the chairperson of the Council of High-Tech Medical Complexes, and members of the Council shall be composed of vice ministers, vice commissioners, or other public officials equivalent thereto of relevant central administrative agencies as prescribed by Presidential Decree, vice heads of the local governments having jurisdiction over the high-tech medical complexes, and private-sector experts in relevant fields. |
| (2) | One executive secretary may be appointed to support the operation of the Council of High-Tech Medical Complexes; in such cases, the executive secretary shall be a member of the Senior Executive Service of the Ministry of Health and Welfare and appointed by the Minister of Health and Welfare. |
| (3) | A secretariat may be established within the Ministry of Health and Welfare to efficiently handle the business affairs of the Council of High-Tech Medical Complexes. |
| (4) | The Minister of Health and Welfare may request the heads of relevant administrative agencies or corporations and organizations (limited to those engaged in the development of complexes, etc. or in medical research and development) to dispatch public officials or executives and employees of such corporations or organizations, if necessary for the efficient operation of the secretariat under paragraph (3). |
| (5) | Except as provided in paragraphs (1) through (4), matters necessary for the composition and operation of the Council of High-Tech Medical Complexes and the operation of the secretariat shall be prescribed by Presidential Decree. |
[This Article Wholly Amended on Jan. 9, 2024]
| Article 29 (Request for submission of data) |
| (1) | The Council of High-Tech Medical Complexes may request the heads of relevant central administrative agencies and the heads of relevant local governments to submit materials necessary for consultation; in such cases, the heads of central administrative agencies and the heads of relevant local governments in receipt of such request shall comply with such request unless there is good cause. <Amended on Jan. 9 2024> |
| (2) | The chairperson of the Council of High-Tech Medical Complexes may request the heads of relevant administrative agencies or private-sector experts to attend meetings of the Council, if necessary for consultation. <Amended on Jan. 9 2024> |
| Article 30 Deleted. <Oct. 24, 2017> |
CHAPTER VI SUPPLEMENTARY PROVISIONS
| Article 31 (Approval for occupancy) |
| (1) | Any person who desires to move into a high-tech medical complex for the purpose of research and development of medical services shall obtain approval of the Minister of Health and Welfare. <Amended on Jan. 18, 2010> |
| (2) | Any person who has obtained the approval for occupancy under paragraph (1) shall, when he or she intends to make a change in any important matter specified by Presidential Decree among the approved matters, obtain approval of the Minister of Health and Welfare. <Amended on Jan. 18, 2010> |
| (3) | The Minister of Health and Welfare may, if any resident research and development institute of medical services falls under any of the following subparagraphs but fails to take measures in compliance with an order issued by the Minister of Health and Welfare to take corrective measures within a prescribed period for performance not exceeding six months, cancel the approval for occupancy; provided, if subparagraph 1 applies, the approval for occupancy shall be cancelled: <Amended on Jan. 18, 2010; Apr. 30, 2019> |
| 1. | If the resident research and development institute of medical services has obtained the approval for occupancy under paragraph (1) or the approval for change under paragraph (2) by fraud or other improper means; |
| 2. | If the resident research and development institute of medical services fails to commence works for the installation of facilities or the construction of a building within 1 year without good cause; |
| 3. | If the resident research and development institute of medical services is unable to install facilities or erect a building; |
| 4. | If the resident research and development institute of medical services fails to commence the relevant business within six months, or has not engaged in the business for six months or longer, without any justifiable reason after facilities or a building was completed; |
| 5. | If a person who had obtained the approval for occupancy fails to obtain approval for a change thereof in violation of paragraph (2); |
| 6. | If a person who has obtained approval for import under Article 23 (2) or 24 (2) breaches any condition of the approval or fails to use the imported item for the purpose of research and development of medical services. |
| (4) | Deleted. <Dec. 29, 2015> |
| (5) | When intending to cancel the approval for occupancy under paragraph (3), the Minister of Health and Welfare shall hold a hearing. <Added on Apr. 30, 2019> |
| (6) | Matters necessary for the procedure for the approval for occupancy or the cancellation of approval for occupancy under paragraph (1) or (3) shall be prescribed by Presidential Decree. <Amended on Apr. 30, 2019> |
| Article 32 (Delegation or entrustment of administrative authority) |
| (1) | The head of each central administrative agency may delegate part of his or her authority under this Act to heads of affiliated agencies under his or her control or heads of competent metropolitan/provincial local government, as prescribed by Presidential Decree. |
| (2) | The head of each central administrative agency may entrust the private sector with part of the affairs under his or her control concerning high-tech medical complexes under this Act, as prescribed by Presidential Decree. |
| Article 33 (Legal fiction as public officials for purposes of penalty provisions) |
A member of the Council of High-Tech Medical Complexes under Article 28 who is not a public official shall be deemed a public official for the purpose of applying Articles 127 and 129 through 132 of the Criminal Act. <Amended on Jan. 9 2024>
[This Article Added on Apr. 30, 2019]
CHAPTER VII PENALTY PROVISIONS
| Article 34 (Penalty provisions) |
Any person who falls under any of the following subparagraphs shall be punished by imprisonment for not more than two years or by a fine not exceeding 20 million won:
| 1. | A person who moves into a high-tech medical complex without obtaining the approval for occupancy in violation of Article 31 (1) or who changes any of the matters approved for occupancy without obtaining approval in violation of paragraph (2) of the same Article; |
| 2. | A person who obtains approval under Article 31 (1) or (2) by fraud or other improper means. |
[This Article Added on Apr. 30, 2019]
| Article 35 (Joint penalty provisions) |
If the representative of a legal entity or an agent, servant or other employee of a legal entity or individual commits an offense provided for in Article 34 in course of performing the duties of the legal entity or individual, not only shall the offender be punished accordingly, but the legal entity or individual shall be punished by a fine pursuant to the said Article; provided, this shall not apply where the legal entity or individual has not been negligent in giving due attention and supervision concerning the relevant duties to prevent such offense.
[This Article Added on Apr. 30, 2019]
ADDENDA <Act No. 9035, Mar. 28, 2008>
| (1) | (Enforcement date) This Act shall enter into force one month after the date of its promulgation. |
| (2) | (Transitional measures concerning the Financial Investment Services and Capital Markets Act) The private equity funds under Article 11 (4) 3 are deemed the private equity funds under the Indirect Investment Asset Management Business Act until before February 4, 2009. |
ADDENDA <Act No. 9306, Dec. 31, 2008>
This Act shall enter into force on the date of its promulgation.
ADDENDA <Act No. 9366, Jan. 30, 2009>
Article 1 (Enforcement date)
This Act shall enter into force 6 months after the date of its promulgation.
Articles 2 through 7 Omitted.
Article 8 Omitted.
Article 9 Omitted.
ADDENDA <Act No. 9685, May 21, 2009>
Article 1 (Enforcement date)
This Act shall enter into force 6 months after the date of its promulgation.
Articles 2 through 6 Omitted.
Article 7 Omitted.
Article 8 Omitted.
ADDENDA <Act No. 9932, Jan. 18, 2010>
Article 1 (Enforcement date)
This Act shall enter into force 2 months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 5 Omitted.
ADDENDA <Act No. 10512, Mar. 30, 2011>
Article 1 (Enforcement date)
This Act shall enter into force 1 year after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 5 Omitted.
Article 6 Omitted.
ADDENDA <Act No. 10564, Apr. 7, 2011>
Article 1 (Enforcement date)
This Act shall enter into force 6 months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 7 Omitted.
Article 8 Omitted.
Article 9 Omitted.
ADDENDA <Act No. 11020, Aug. 4, 2011>
Article 1 (Enforcement date)
This Act shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 9 Omitted.
Article 10 Omitted.
Article 11 Omitted.
ADDENDA <Act No. 11141, Dec. 31, 2011>
Article 1 (Enforcement date)
This Act shall enter into force on September 1, 2012. (Proviso Omitted.)
Articles 2 through 20 Omitted.
Article 21 Omitted.
Article 22 Deleted.
ADDENDA <Act No. 11232, Jan. 26, 2012>
Article 1 (Enforcement date)
This Act shall enter into force 6 months after the date of its promulgation.
Articles 2 through 10 Omitted.
Article 11 Omitted.
Article 12 Omitted.
ADDENDA <Act No. 11250, Feb. 1, 2012>
Article 1 (Enforcement date)
This Act shall enter into force 1 year after the date of its promulgation.
Articles 2 through 5 Omitted.
Article 6 Omitted.
Article 7 Omitted.
ADDENDA <Act No. 11690, Mar. 23, 2013>
Article 1 (Enforcement date)
| (1) | This Act shall enter into force on the date of its promulgation. |
Articles 2 through 5 Omitted.
Article 6 Omitted.
Article 7 Omitted.
ADDENDA <Act No. 13448, Jul. 24, 2015>
Article 1 (Enforcement date)
This Act shall enter into force 3 months from the date of its promulgation. (Proviso Omitted.)
Articles 2 through 18 Omitted.
Article 19 Omitted.
Article 20 Omitted.
ADDENDUM <Act No. 13665, Dec. 29, 2015>
This Act shall enter into force on the date of its promulgation.
ADDENDUM <Act No. 13748, Jan. 6, 2016>
This Act shall enter into force on the date of its promulgation; provided, the amended provisions of Article 26-2 shall enter into force 6 months after the promulgation thereof.
ADDENDA <Act No. 14127, Mar. 29, 2016>
Article 1 (Enforcement date)
This Act shall enter into force 6 months after the date of its promulgation.
Articles 2 through 10 Omitted.
Article 11 Omitted.
ADDENDA <Act No. 14839, Jul. 26, 2017>
Article 1 (Enforcement date)
| (1) | This Act shall enter into force on the date of its promulgation; provided, the provisions amending any Act that was promulgated before this Act enters into force but has yet to enter into force, among the Acts amended under Article 5 of the Addenda, shall enter into force on the respective date the relevant Act enters into force. |
Articles 2 through 4 Omitted.
Article 5 Omitted.
Article 6 Omitted.
ADDENDUM <Act No. 14930, Oct. 24, 2017>
Article 1 (Enforcement date)
This Act shall enter into force 1 year after the date of its promulgation.
Article 2 (Applicability to comprehensive plans)
The amended provisions of Article 10 (1) and (2) shall begin to apply to comprehensive plans established after this Act enters into force.
Article 3 (Transitional measures concerning medical innovation foundation)
| (1) | As at the time this Act enters into force, the Osong Medical Innovation Foundation and the Daegu Gyeongbuk Medical Innovation Foundation, which were established as incorporated foundations with approval from the Minister of Education, Science and Technology, the Minister of Knowledge Economy, or the Minister of Health and Welfare under Article 32 of the Civil Act, shall be deemed medical innovation foundations established under the amended provisions of Article 11. (2) As at the time this Act enters into force, the New Drug Development Support Center, Advanced Medical Device Development Support Center, Laboratory Animal Center, and Drug Manufacturing Center (in the case of the Osong Foundation, the Biopharmaceutical Manufacturing Center) that were installed within the Osong Medical Innovation Foundation and the Daegu Gyeongbuk Medical Innovation Foundation, respectively, shall be deemed medical R&D support centers established under the amended provisions of Article 11 (4). |
ADDENDA <Act No. 15309, Dec. 26, 2017>
Article 1 (Enforcement date)
This Act shall enter into force 3 months from the date of its promulgation. (Proviso Omitted.)
Article 2 Omitted.
Article 3 Omitted.
Article 4 Omitted.
ADDENDUM <Act No. 15909, Dec. 11, 2018>
This Act shall enter into force 3 months after the date of its promulgation.
ADDENDA <Act No. 16250, Jan. 15, 2019>
Article 1 (Enforcement date)
This Act shall enter into force 6 months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 4 Omitted.
Article 5 Omitted.
ADDENDA <Act No. 16407, Apr. 30, 2019>
Article 1 (Enforcement date)
This Act shall enter into force 6 months after the date of its promulgation.
Article 2 Omitted.
Article 3 (Relationship to other statutes or regulations)
Where any other statute or regulation cites the former Special Act on the Designation and Support of High-Tech Medical Complexes or any provision thereof at the time this Act enters into force, such citation shall be deemed a citation of this Act or the relevant provision of this Act, if any provision of this Act corresponds thereto.
ADDENDA <Act No. 16998, Feb. 11, 2020>
Article 1 (Enforcement date)
This Act shall enter into force 6 months after the date of its promulgation.
Articles 2 through 9 Omitted.
Article 10 Omitted.
Article 11 Omitted.
ADDENDA <Act No. 18128, Apr. 20, 2021>
Article 1 (Enforcement date)
This Act shall enter into force 6 months after the date of its promulgation.
Articles 2 through 9 Omitted.
Article 10 Omitted.
ADDENDA <Act No. 19959, Jan. 9, 2024>
Article 1 (Enforcement date)
This Act shall enter into force 6 months after the date of its promulgation.
Articles 2 through 4 Omitted.
Article 5 (Transitional measures concerning the amendment of the Special Act on the Promotion of High-Tech Medical Complexes)
| (1) | A committee member who was commissioned under the previous provisions of Article 28 of the Special Act on the Promotion of High-Tech Medical Complexes before the enforcement of this Act and whose term of office remains in effect shall be deemed to have completed their term on the enforcement date of this Act. |
| (2) | For the purpose of applying penalty provisions to any act committed before the enforcement of this Act, the deemed public official status of members who are not public officials of the committee on high-tech medical complexes under the previous provisions of Article 27 of the Special Act on the Promotion of High-Tech Medical Complexes shall be governed by the previous provisions, notwithstanding the amended provisions of Article 33 of that Act. |
ADDENDUM <Act No. 20224, Feb. 6, 2024>
This Act shall enter into force 3 months after the date of its promulgation.
ADDENDA <Act No. 21065, Oct. 1, 2025>
Article 1 (Enforcement date)
This Act shall enter into force on the date of its promulgation; provided, the amendments to the statutes to be amended under Article 7 of the Addenda, which were promulgated before this Act enters into force but the enforcement dates of which have yet to arrive, shall enter into force on the enforcement date of the relevant statute.
Articles 2 through 6 Omitted.
Article 7 Omitted.
Article 8 Omitted.