SPECIAL ACT ON THE DESIGNATION AND SUPPORT OF HIGH-TECH MEDICAL COMPLEXES
Act No. 9035, Mar. 28, 2008
Amended by Act No. 9306, Dec. 31, 2008
Act No. 9366, Jan. 30, 2009
Act No. 9685, May 21, 2009
Act No. 9932, Jan. 18, 2010
Act No. 10512, Mar. 30, 2011
Act No. 10564, Apr. 7, 2011
Act No. 11020, Aug. 4, 2011
Act No. 11141, Dec. 31, 2011
Act No. 11232, Jan. 26, 2012
Act No. 11250, Feb. 1, 2012
Act No. 11690, Mar. 23, 2013
Act No. 13448, Jul. 24, 2015
Act No. 13665, Dec. 29, 2015
Act No. 13748, Jan. 6, 2016
Act No. 14127, Mar. 29, 2016
Act No. 14839, Jul. 26, 2017
Act No. 14930, Oct. 24, 2017
Act No. 15309, Dec. 26, 2017
Act No. 15909, Dec. 11, 2018
Act No. 16250, Jan. 15, 2019
Act No. 16407, Apr. 30, 2019
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 by Act No. 16407, Apr. 30, 2019>
The terms used in this Act shall be defined as follows: <Amended by Act No. 9932, Jan. 18, 2010; Act No. 13748, 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; |
| 3. | The term "medical appliances" means medical appliances as defined in the Medical Devices 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; |
| (iii) | A research institute; |
| (iv) | A government-funded institution or similar; |
| 7. | Deleted; <by Act No. 14930, 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) |
| (1) | Chapter IV (Articles 20 through 26) of this Act that provides for special cases in order to relax regulation shall take precedence over other Acts and subordinate statutes: Provided, That if any other Act or subordinate statute has a provision that relaxes regulation more than the special cases for regulation under this Act, the provision of such Act or subordinate statute 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 Act and subordinate statutes. |
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 formulate a plan for the development of a high-tech medical complex (hereinafter referred to as "development plan"), hearing opinions of heads of appropriate central administrative agencies and the head of the metropolitan/provincial local government having jurisdiction over the area in which it is planned to establish the high-tech medical complex, and finalize the plan, subject to deliberation and resolution by the committee on high-tech medical complexes under Article 27 (hereinafter referred to as the "committee on high-tech medical complexes"). The same shall also apply to any revision to the development plan. <Amended by Act No. 9306, Dec. 31, 2008; Act No. 9932, Jan. 18, 2010> |
| (2) | The Minister of Health and Welfare shall take into consideration the balanced development of national land in formulating a development plan. <Amended by Act No. 9306, Dec. 31, 2008; Act No. 9932, Jan. 18, 2010> |
| (3) | Each development plan shall include the following: <Amended by Act No. 14930, 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) | In selecting a site for a high-tech medical complex, the Minister of Health and Welfare shall choose an area with better conditions out of the whole or part of any of the following areas (hereinafter referred to as "complex or the like"): <Amended by Act No. 9306, Dec. 31, 2008; Act No. 9366, Jan. 30, 2009; Act No. 9932, Jan. 18, 2010; Act No. 11020, Aug. 4, 2011; Act No. 11232, Jan. 26, 2012; Act No. 15309, Dec. 26, 2017> |
| 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; |
| 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 requirements for site selection in cases where the Minister of Health and Welfare intends to select the site for a high-tech medical complex under paragraph (1) are as follows: <Amended by Act No. 9306, Dec. 31, 2008; Act No. 9932, 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 an area other than any complex or the like is deemed better than the complex or the like in conditions for the site selection under subparagraphs of paragraph (2), the Minister of Health and Welfare may choose the area as the site for a high-tech medical complex, subject to deliberation by the committee on high-tech medical complexes. <Amended by Act No. 9306, Dec. 31, 2008; Act No. 9932, Jan. 18, 2010> |
| 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 by Act No. 9932, 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 or the like 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 or the like 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 by Act No. 11690, 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 by Act No. 11690, 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 by Act No. 9932, 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 Energy, 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 affairs under the control of each of them for the fostering of high-tech medical complexes every five years, as prescribed by Presidential Decree. <Amended by Act No. 9306, Dec. 31, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013; Act No. 14839, Jul. 26, 2017; Act No. 14930, Oct. 24, 2017> |
| (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 by Act No. 9306, Dec. 31, 2008; Act No. 9932, Jan. 18, 2010; Act No. 14930, Oct. 24, 2017> |
| (3) | The Minister of Health and Welfare shall finalize the comprehensive plan formulated pursuant to paragraph (2), subject to deliberation and resolution by the committee on high-tech medical complexes under Article 27, and notify the heads of the operating agencies thereof. The same shall also apply to any revision to the comprehensive plan. <Newly Inserted by Act No. 9306, Dec. 31, 2008; Act No. 9932, Jan. 18, 2010> |
| (4) | The comprehensive plan shall include the following: <Amended by Act No. 9306, Dec. 31, 2008; Act No. 14930, 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 by Act No. 9306, 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: <Newly Inserted by Act No. 15909, 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. <Newly Inserted by Act No. 15909, Dec. 11, 2018> |
| (5) | A foundation under paragraph (1) shall perform the following duties: |
| 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 by Act No. 15909, 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 budgetary limits. |
| (9) | The State and each local government may provide support to any of the following investment associations or companies organized or established mainly for the purpose of investing in resident research and development institutes of medical services: |
[This Article Wholly Amended by Act No. 14930, 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 by Act No. 14930, 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 by Act No. 13665, 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 by Act No. 14930, 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 by Act No. 9685, May 21, 2009; Act No. 11690, Mar. 23, 2013; Act No. 14930, Oct. 24, 2017; Act No. 16407, 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/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 by Act No. 11690, Mar. 23, 2013; Act No. 16407, Apr. 30, 2019> |
| (3) | Necessary matters concerning 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 by Act No. 14930, 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 by Act No. 14930, 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 by Act No. 14930, 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 by Act No. 14930, 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 by Act No. 14930, Oct. 24, 2017> |
| Article 19 (Allowance of Voluntary Suspension of Employment or Currently Holding Office by Researchers of National or Public Research Institutes) |
| (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 by Act No. 14930, Oct. 24, 2017>
| Article 21 (Special Cases concerning the Medical Service Act) |
| (1) | Notwithstanding Articles 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 by Act No. 9932, 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 by Act No. 9932, 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 by Act No. 9932, Jan. 18, 2010> |
| Article 22 (Special Cases concerning the National Health Insurance Act) |
| (1) | Notwithstanding Article 39 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 by Act No. 9932, Jan. 18, 2010; Act No. 11141, 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 Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 9932, 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 Ordinance of the Prime Minister. 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 by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013; Act No. 14930, 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 by Act No. 11690, Mar. 23, 2013; Act No. 14930, 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 by Act No. 10512, Mar. 30, 2011; Act No. 11690, Mar. 23, 2013; Act No. 16250, 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 by Act No. 9932, Jan. 18, 2010; Act No. 10512, Mar. 30, 2011; Act No. 11690, Mar. 23, 2013; Act No. 14930, Oct. 24, 2017; Act No. 16250, Jan. 15, 2019> |
| (5) | Necessary matters concerning 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 Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 9932, 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 Ordinance of the Prime Minister 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 Ordinance of the Prime Minister. 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 by Act No. 9932, Jan. 18, 2010; Act No. 10564, Apr. 7, 2011; Act No. 11690, Mar. 23, 2013; Act No. 14930, 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 by Act No. 10564, Apr. 7, 2011; Act No. 11690, Mar. 23, 2013; Act No. 14930, 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 by Act No. 10564, Apr. 7, 2011; Act No. 11690, 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 by Act No. 9932, Jan. 18, 2010; Act No. 10564, Apr. 7, 2011; Act No. 11690, Mar. 23, 2013; Act No. 14930, Oct. 24, 2017> |
| (5) | Necessary matters concerning 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 Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 10564, 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 Ordinance 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 by Act No. 9932, 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 by Act No. 11250, 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 by Act No. 11250, Feb. 1, 2012> |
| Article 26 (Special Cases for the Patent Act) |
Notwithstanding Article 61 of the Patent Act, the Commissioner 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.
| Article 26-2 (Installation of Production Facilities for Resident Research and Development Institute of Medical Services) |
| (1) | A resident research and development institute may install small-scale production facilities prescribed by Presidential Decree for medicines or medical appliances researched and developed within a high-tech medical complex. |
| (2) | In case of installation pursuant paragraph (1), approval from the Minister of Health and Welfare shall be obtained. The same shall apply to change significant matters in accordance with Presidential Decree among from those approved. |
[This Article Newly Inserted by Act No. 13748, Jan. 6, 2016]
CHAPTER V COMMITTEE ON HIGH-TECH MEDICAL COMPLEXES
| Article 27 (Establishment of Committee on High-Tech Medical Complexes) |
The Minister of Health and Welfare shall establish a committee on high-tech medical complexes under his/her control, to deliberate on the following matters in connection with fostering high-tech medical complexes: <Amended by Act No. 14930, Oct. 24, 2017; Act No. 16407, Apr. 30, 2019>
| 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 deliberation by the committee on high-tech medical complexes and the matters brought by the committee chairperson to the committee for deliberation as necessary for promoting the development of high-tech medical complexes. |
| Article 28 (Composition and Operation) |
| (1) | The committee on high-tech medical complexes shall be comprised of ex officio members, including the committee chairperson, and not more than 10 commissioned members. |
| (2) | The Minister of Health and Welfare shall take the chair of the committee, and the Vice Minister or Vice Administrator or other equivalent public official of each competent central administrative agency specified by Presidential Decree and the deputy head of each metropolitan/provincial local government having jurisdiction over high-tech medical complexes shall consist of other ex officio members. <Amended by Act No. 16407, Apr. 30, 2019> |
| (3) | Commissioned members shall be commissioned by the committee chairperson from among those able to contribute to the development and operation of high-tech medical complexes with ample knowledge and experience. |
| (4) | A majority of the incumbent committee members of the committee on high-tech medical complexes shall constitute a quorum, and any decision thereof shall require the concurring vote of at least a majority of those present. |
| (5) | The committee on high-tech medical complexes shall have one secretary who shall assist in the operation of the committee. In such cases, a person who is appointed by the Minister of Health and Welfare from among the public officials belonging to the Senior Civil Service of the Ministry of Health and Welfare shall serve as the secretary. <Amended by Act No. 9306, Dec. 31, 2008; Act No. 9932, Jan. 18, 2010; Act No. 16407, Apr. 30, 2019> |
| (6) | The secretariat shall be established in the Ministry of Health and Welfare to efficiently handle the affairs of the committee on high-tech medical complexes. <Newly Inserted by Act No. 14930, Oct. 24, 2017> |
| (7) | If necessary to efficiently operate the secretariat established under paragraph (6), the Minister of Health and Welfare may request the head of a related administrative agency, corporation, or organization (limited to a corporation or organization that performs duties related to development of the complex or the like and research and development of medical services) to dispatch public officials or executive officers and employees of the corporation or organization. <Newly Inserted by Act No. 14930, Oct. 24, 2017> |
| (8) | Other matters necessary for the composition and operation of the committee on high-tech medical complexes and the operation, etc. of the secretariat shall be prescribed by Presidential Decree. <Amended by Act No. 14930, Oct. 24, 2017> |
| Article 29 (Request for Submission of Data) |
| (1) | The committee on high-tech medical complexes may request the head of any appropriate central administrative agency or the head of the competent metropolitan/provincial local government to submit data necessary for deliberation. In such cases, the head of any appropriate central administrative agency or the head of the competent metropolitan/provincial local government shall, upon receiving such request, comply with the request, unless there are any exceptional circumstances to the contrary. |
| (2) | The chairperson of the committee on high-tech medical complexes may, if necessary for deliberation, request the head of any appropriate central administrative agency or any private expert to make an appearance in the committee. |
| Article 30 Deleted. <by Act No. 14930, Oct. 24, 2017> |
CHAPTER VI SUPPLEMENTARY PROVISIONS
| Article 31 (Approval for Occupancy, etc.) |
| (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 by Act No. 9932, Jan. 18, 2010> |
| (2) | Any person who has obtained the approval for occupancy under paragraph (1) shall, when he/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 by Act No. 9932, 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, That if subparagraph 1 applies, the approval for occupancy shall be cancelled: <Amended by Act No. 9932, Jan. 18, 2010; Act No. 16407, 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 withing one year without any justifiable reason; |
| 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. <by Act No. 13665, 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. <Newly Inserted by Act No. 16407, Apr. 30, 2019> |
| (6) | Necessary matters concerning 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 by Act No. 16407, Apr. 30, 2019> |
| Article 32 (Delegation or Entrustment of Administrative Authority) |
| (1) | The head of each central administrative agency may delegate part of his/her authority under this Act to heads of affiliated agencies under his/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/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) |
[This Article Newly Inserted by Act No. 16407, 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 Newly Inserted by Act No. 16407, 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, That 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 Newly Inserted by Act No. 16407, Apr. 30, 2019]
ADDENDA
| (1) | (Enforcement Date) This Act shall enter into force three months after the date of its promulgation. |
ADDENDUM <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 six months after the date of its promulgation.
Articles 2 through 9 Omitted.
ADDENDA <Act No. 9685, May 21, 2009>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation.
Articles 2 through 8 Omitted.
ADDENDA <Act No. 9932, Jan. 18, 2010>
Article 1 (Enforcement Date)
This Act shall enter into force two 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 one year after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 6 Omitted.
ADDENDA <Act No. 10564, Apr. 7, 2011>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 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 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 22 Omitted.
ADDENDA <Act No. 11232, Jan. 26, 2012>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation.
Articles 2 through 12 Omitted.
ADDENDA <Act No. 11250, Feb. 1, 2012>
Article 1 (Enforcement Date)
This Act shall enter into force one year after the date of its promulgation.
Articles 2 through 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 7 Omitted.
ADDENDA <Act No. 13448, Jul. 24, 2015>
Article 1 (Enforcement Date)
This Act shall enter into force three months after its promulgation. (Proviso Omitted.)
Articles 2 through 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, That the amended provisions of Article 26-2 shall enter into force six months after the date of its promulgation.
ADDENDA <Act No. 14127, Mar. 29, 2016>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation.
Articles 2 through 11 Omitted.
ADDENDA <Act No. 14839, Jul. 26, 2017>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation: Provided, That the amended provisions of the Acts, which were promulgated before this Act enters into force, but the date on which they are to enter into force, has not arrived yet, among the Acts amended pursuant to Article 5 of the Addenda, shall enter into force on the enforcement dates of such Acts, respectively.
Articles 2 through 6 Omitted.
ADDENDA <Act No. 14930, Oct. 24, 2017>
Article 1 (Enforcement Date)
This Act shall enter into force one year after the date of its promulgation.
Article 2 (Applicability to Comprehensive Plan)
The amended provisions of Article 10 (1) and (2) shall begin to apply to the first comprehensive plan formulated after this Act enters into force. Article 3 (Transitional Measures concerning Medical Innovation Foundations)
| (1) | The Osong Medical Innovation Foundation and Daegu-Gyeongbuk Medical Innovation Foundation established as incorporated foundations with permission of the Minister of Education, Science and Technology, the Minister of Knowledge Economy, and the Minister of Health and Welfare under Article 32 of the Civil Act as at the time this Act enters into force, shall be deemed a medical innovation foundation established under the amended provisions of Article 11. |
| (2) | The new drug development centers, medical device development centers, laboratory animal centers, and clinical drug manufacturing center (for the Osong Medical Innovation Foundation, the bio pharmaceuticals manufacturing center) established in the Osong Medical Innovation Foundation and Daegu-Gyeongbuk Medical Innovation Foundation, respectively, as at the time this Act enters into force, shall be deemed a center for supporting research and development of medical services 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 three months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 4 Omitted.
ADDENDUM <Act No. 15909, Dec. 11, 2018>
This Act shall enter into force three months after the date of its promulgation.
ADDENDA <Act No. 16250, Jan. 15, 2019>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 5 Omitted.
ADDENDA <Act No. 16407, Apr. 30, 2019>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation.
Article 2 Omitted.
Article 3 (Relationship to Other Statutes and Regulations)
At the time this Decree enters into force, references in other statutes and regulations to the former Special Act on the Designation and Support of High-Tech Medical Complexes or to the provisions thereof, if this Act includes any provisions corresponding thereto, shall be deemed references to this Act or the corresponding provisions thereof in lieu of the previous provisions.