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ENFORCEMENT DECREE OF THE HEALTH AND MEDICAL SERVICE TECHNOLOGY PROMOTION ACT

Wholly Amended by Presidential Decree No. 21048, Sep. 26, 2008

Amended by Presidential Decree No. 21461, Apr. 30, 2009

Presidential Decree No. 21835, Nov. 20, 2009

Presidential Decree No. 22003, Jan. 27, 2010

Presidential Decree No. 22075, Mar. 15, 2010

Presidential Decree No. 22163, May 18, 2010

Presidential Decree No. 22914, May 3, 2011

Presidential Decree No. 22977, jun. 24, 2011

Presidential Decree No. 23615, Feb. 3, 2012

Presidential Decree No. 24077, Aug. 31, 2012

Presidential Decree No. 25123, Jan. 28, 2014

Presidential Decree No. 25649, Oct. 8, 2014

Presidential Decree No. 26092, Feb. 10, 2015

Presidential Decree No. 26504, Sep. 1, 2015

Presidential Decree No. 27129, May 10, 2016

Presidential Decree No. 27205, May 31, 2016

Presidential Decree No. 27506, Sep. 22, 2016

 Article 1 (Purpose)
The purpose of this Decree is to provide for matters delegated from the Health and Medical Service Technology Promotion Act and those necessary for the enforcement thereof.
 Article 2 (Health and Medical Technology)
The specific scope of health and medical technology referred to in Article 2 (2) of the Health and Medical Service Technology Promotion Act (hereinafter referred to as the "Act") shall be as specified in attached Table 1. <Amended by Presidential Decree No. 23615, Feb. 3, 2012>
 Article 2-2 (Details of Master Plans for Promotion of Health and Medical Technology)
"Matters important for the development of health and medical technology prescribed by Presidential Decree" in Article 4 (3) 6 of the Act, means the following:
1. Matters concerning the preparation, supplementation, and development of a health and medical technology classification system;
2. Matters concerning the analysis of the current status of investments in health and medical research and development;
3. Matters concerning the management of the benefits of health and medical technology and the preparation of a system for dissemination of such benefits;
4. Matters concerning promoting commercialization of health and medical technology and the transfer of technology;
5. Matters concerning the creation of infrastructure for health and medical technological research and circumstances for the industrialization thereof;
6. Matters concerning international cooperation in health and medical technology.
[This Article Newly Inserted by Presidential Decree No. 25123, Jan. 28, 2014]
 Article 2-3 (Cooperation in Formulation of Master Plans, etc. for Promotion of Health and Medical Technology)
(1) Where necessary to formulate a master plan for the promotion of health and medical technology (hereinafter referred to as "master plan") and yearly action plans (hereinafter referred to as "action plan") pursuant to Article 4 (6) of the Act, the Minister of Health and Welfare may prepare guidelines for the formulation of a plan for the field under the jurisdiction of each relevant central administrative agency and notify the head of each relevant central administrative agency of such guidelines.
(2) The head of each relevant central administrative agency shall formulate a plan for the field under its jurisdiction in accordance with guidelines for the formulation thereof under paragraph (1) and submit such plan to the Minister of Health and Welfare.
(3) Where necessary to formulate a master plan and an action plan, the Minister of Health and Welfare may request the head of each relevant central administrative agency to submit data on the current status of health and medical technology in the field under its jurisdiction; the results of the preceding year; and the prospects of the development of health and medical technology, pursuant to Article 4 (6) of the Act.
[This Article Newly Inserted by Presidential Decree No. 25123, Jan. 28, 2014]
 Article 3 (Standards of Research Institutes, etc. Affiliated with Enterprises)
(1) "Research institute affiliated with an enterprise meeting standards prescribed by Presidential Decree" in Article 5 (2) 4 of the Act, means a research institute affiliated with an enterprise which has long-term human resources exclusively in charge of research in the field of health and medical technology among those affiliated with enterprises recognized under Article 14-2 (1) of the Basic Research Promotion and Technology Development Support Act. <Amended by Presidential Decree No. 22977, Jun. 24, 2011; Presidential Decree No. 27506, Sep. 22, 2016>
(2) "Other research institutions or organizations in the field of health and medical technology prescribed by Presidential Decree" in Article 5 (2) 6 of the Act means research institutions or organizations approved by the Minister of Health and Welfare, which employ at least five employees exclusively in charge of research, including at least two persons with at least three years of research experience in the field of health and medical technology and have independent research facilities. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 4 (Methods, etc. of Selecting Research Tasks)
(1) The Minister of Health and Welfare shall select research tasks for each year and in each field under Article 5 of the Act, following deliberation by the Deliberative Committee on Health and Medical Technology Policy (hereinafter referred to as the "Committee") established under Article 6 of the Act. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(2) Necessary matters concerning the selection of research tasks referred to in paragraph (1), shall be prescribed by the Minister of Health and Welfare. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 5 (Methods of Executing Agreements)
(1) The Minister of Health and Welfare shall execute an agreement under Article 5 (2) of the Act, with the head of an institution that takes charge of and conducts the relevant research (hereinafter referred to as "institution in charge of research") among institutions falling under any subparagraph of Article 5 (2) of the Act. In such cases, where expenses incurred in conducting research include contributions from the private sector, or technological development expenses incurred by an enterprise (including spots; hereinafter the same shall apply), the head of an institution in charge of research shall first execute an agreement with a person who bears such expenses. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(2) An agreement referred to in paragraph (1) shall provide for the following: <Amended by Presidential Decree No. 22163, May 18, 2010>
1. The scope of research tasks, methods of conducting research tasks, and the person in charge of research;
2. Research and development expenses and methods of paying such expenses;
3. Reporting of the findings of research and development;
4. Vesting, utilization, and transfer of the findings of research and development;
5. Collection, use, and payment of technology licensing royalties based on the utilization of the findings of research and development;
6. Measures to be taken following the evaluation of the findings of research and development;
7. Use and management of research and development expenses;
8. Alteration and cancellation of the agreement;
9. Measures to be taken against the violation of the agreement;
10. Matters concerning the observance of research ethics and security management;
11. Other matters accompanying research and development.
 Article 6 (Management, Payment, etc. of Contributions)
(1) The head of an institution in charge of research in receipt of contributions from the Government or private sector, or technological development expenses incurred by an enterprise (hereinafter referred to as "contributions, etc.") pursuant to Article 5 (3) of the Act, shall establish a separate account and manage such contributions, etc.
(2) The Minister of Health and Welfare may pay contributions under Article 5 (4) of the Act in lump sum or in installments, in consideration of the scale of research and development tasks, the timing for commencing research, the financial status of the Government, etc. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 7 (Use of Contributions, etc. and Reporting, etc. of Details thereof)
(1) Where the head of an institution in charge of research receives contributions, etc. pursuant to Article 6, he/she shall use such contributions, etc. for the following purposes only, as prescribed and publicly notified by the Minister of Health and Welfare: <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
1. Personnel expenses for researchers;
2. Expenses incurred in purchasing, installing, leasing, and operating research facilities (including equipment and materials);
3. Expenses incurred in purchasing materials;
4. Expenses incurred in importing technology and conducting technical information activities;
5. Expenses incurred in research management and technical guidance;
6. Expenses incurred in inviting foreign experts and educating and training researchers;
7. Expenses incurred in establishing an overseas research institute and operating expenses;
8. Development preservation expenses;
9. Other expenses directly accompanied by research and development.
(2) The head of an institution in charge of research shall annually report the details of use of contributions, etc. under paragraph (1) to the Minister of Health and Welfare within three months after health and medical technological research and development projects (hereinafter referred to as "research and development projects") under in Article 5 (1) of the Act for the relevant year are completed. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 8 (Composition of Committee)
(1) The Committee shall be comprised of not exceeding 20 members, including one chairperson and one vice chairperson.
(2) Members of the Committee shall be appointed or commissioned by the Minister of Health and Welfare, from among any of the following: Provided, That members falling under subparagraph 2 shall not exceed five persons: <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
1. Those with expert knowledge of and extensive experience in health and medical technology;
2. Public officials in general service belonging to the Senior Executive Service of the Ministry of Health and Welfare.
(3) The chairperson and the vice chairperson of the Committee shall be commissioned by the Minister of Health and Welfare, from among members falling under paragraph (2) 1. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 9 (Term of Office of Committee Members)
The term of office of Committee members referred to in Article 8 (2) 1 shall be two years, and the term of office of a member filling a vacancy shall be the reminder of the unexpired term of his/her predecessor.
 Article 9-2 (Dismissal, etc. of Committee Members)
Where a committee member falls under any of the following cases, the Minister of Health and Welfare may dismiss such committee member from his/her office or cancel the nomination thereof:
1. Where he/she becomes unable to perform his/her duties due to mental disorder;
2. Where it is found that he/she is involved in any misconduct in connection with his/her duties;
3. Where he/she is deemed unsuitable to continue as a committee member due to neglect of duties, injury to dignity, and other reasons;
4. Where he/she voluntarily informs that it is difficult to perform his/her duties.
[This Article Newly Inserted by Presidential Decree 27129, May 10, 2016]
 Article 10 (Deliberation)
"Important matters concerning the promotion of health and medical technology prescribed by Presidential Decree" in Article 6 (2) 8 of the Act means the following: <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 25123, Jan. 28, 2014>
1. Matters concerning the selection, evaluation, and management of health and medical technological research and development tasks;
2. Matters concerning the discovery and planning of new tasks of health and medical technological research and development;
3. Other matters submitted by the Minister of Health and Welfare to the Committee concerning the promotion of health and medical technology.
 Article 11 (Researchers)
(1) Not more than five researchers may be assigned to the Committee for professional investigation and research concerning matters to be deliberated on by the Committee pursuant to Article 6 (3) of the Act. <Amended by Presidential Decree No. 22163, May 18, 2010>
(2) Researchers referred to in paragraph (1) shall be commissioned by the Minister of Health and Welfare, from among those with expert knowledge in the field of health and medical technology. <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 22163, May 18, 2010>
(3) Researchers referred to in paragraph (1) may be reimbursed for research expenses and travel expenses; the amount of such expenses reimbursed shall be determined by the Minister of Health and Welfare, within budgetary limits. <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 22163, May 18, 2010>
 Article 12 (Administrative Secretaries)
Two administrative secretaries to conduct affairs of the Committee shall be assigned to the Committee; being one researcher designated by the chairperson and one public official of at least Grade IV or public official in general service belonging to the Senior Executive Service designated by the Minister of Health and Welfare, from among public officials of the Ministry of Health and Welfare. <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 22163, May 18, 2010>
 Article 13 (Chairperson)
(1) The chairperson shall represent the Committee and preside over its affairs.
(2) Where the chairperson is unable to perform any of his/her duties due to extenuating circumstances, the vice chairperson shall act on his/her behalf.
 Article 14 (Meetings)
(1) The chairperson shall convene meetings upon request by the Minister of Health and Welfare or by at least one third of all incumbent members. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(2) A majority of all incumbent members shall constitute a quorum at all its meetings, and resolutions shall be passed with the concurrent vote of a majority of members present.
 Article 15 (Allowances, etc.)
Members who attend a Committee meeting may be paid allowances and reimbursed for travel expenses, within budgetary limits: Provided, That members who are public officials in direct relation with the relevant business shall not be paid allowances nor reimbursed for travel expenses.
 Article 16 (Composition, etc. of Working Committees)
(1) For professional research and deliberation and the discovery, planning, evaluation, management, etc. of research and development tasks, working committees by field shall be established under the Committee pursuant to Article 6 (4) of the Act.
(2) Each working committee shall be comprised of not exceeding ten members, including one chairperson, and they shall be commissioned by the Minister of Health and Welfare, from among relevant experts. <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 22163, May 18, 2010>
(3) Each working committee shall conduct research and deliberate on matters delegated from the Committee or instructed by the chairperson of the Committee. <Amended by Presidential Decree No. 22163, May 18, 2010>
(4) Where a member of the working committees falls under any of the following cases, the Minister of Health and Welfare may dismiss such working committee member from his/her office: <Newly Inserted by Presidential Decree 27129, May 10, 2016>
1. Where he/she becomes unable to perform his/her duties due to mental disorder;
2. Where it is found that he/she is involved in any misconduct in connection with his/her duties;
3. Where he/she is deemed unsuitable to continue as a working committee member due to neglect of duties, injury to dignity, and other reasons;
4. Where he/she voluntarily informs that it is difficult to perform his/her duties.
 Article 17 (By-Laws)
Except as otherwise expressly provided for in this Decree, matters necessary for the operation of the Committee and working committees shall be prescribed by the Minister of Health and Welfare. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 18 (Technology Eligible, Standards, and Procedures for Certification of New Health Technology)
(1) Technology eligible for certification of new health technology referred to in Article 8 (1) of the Act shall be any of the following technology, based on the date of certification: <Amended by Presidential Decree No. 22914, May 3, 2011>
1. Technology commercializable within two years, which is fully developed, which has been included in the quantitative evaluation index by manufacturing, testing, or operating (hereinafter referred to as "verification testing") a prototype, etc. from technology established as a theory;
2. Technology which may remarkably improve the performance of an existing product in the future, which is fully developed, which has been included in the quantitative evaluation index through verification testing;
3. Manufacturing process technology which may remarkably improve the productivity or quality of products in the future.
(2) Standards for certification of new health technology referred to in paragraph (1) shall be as follows: <Amended by Presidential Decree No. 22914, May 3, 2011>
1. Original new technology developed in the Republic of Korea, which shall be at least equal to the technology level of developed countries and commercializable;
2. Technology contributable to improving national technological capacity and strengthening international competitiveness for having substantial economic and technological impacts;
3. Technology which will have a quality management system that may maintain the performance of a product presented as development targets in terms of product quality and stability;
4. The effect and necessity of support following the certification of new health technology shall be verified.
(3) Upon receipt of an application for certification referred to in Article 8 (2) of the Act, the Minister of Health and Welfare shall examine whether technology is eligible for certification under paragraph (1) and meets standards for certification under paragraph (2). <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(4) The Minister of Health and Welfare shall post a notice of the prearrangement of certification of new health technology found to meet standards for certification through examination under paragraph (3), including an applicant, the name and details of technology, a technology holder, and the scheduled period of certification, on the website of the Ministry of Health and Welfare, and publicly announce such fact in the Official Gazette or daily newspapers published and distributed nationwide pursuant to the Act on the Promotion of Newspapers, Etc. <Amended by Presidential Decree No. 22003, Jan. 27, 2010; Presidential Decree No. 22075, Mar. 15, 2010>
(5) Any person with an interest in new health technology publicly announced pursuant to paragraph (4), may file an objection with the Minister of Health and Welfare within 30 days from the date of public announcement. Upon receipt of a formal objection, the Minister of Health and Welfare shall examine and review the formal objection and inform the applicant and other interested persons of his/her conclusions thereon. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(6) Where the Minister of Health and Welfare certifies new health technology pursuant to Article 8 (3) of the Act, he/she shall certify new health technology for a fixed period not exceeding three years, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(7) Where a person with certified new health technology intends to obtain an extension of the period of certification under paragraph (6), he/she shall file an application for extension with the Minister of Health and Welfare before the relevant period expires, and if the Minister of Health and Welfare deems it necessary to extend the period of certification of new health technology, he/she may extend the period of certification of new health technology by up to three years. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(8) In addition to matters prescribed in paragraphs (1) through (7), necessary matters concerning procedures, etc. for certification of new health technology shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 19 (Use of Mark Certifying New Health Technology)
(1) A mark certifying new health technology (hereinafter referred to as "certification mark") referred to in Article 8-2 (1) of the Act shall be as specified in attached Table 1-2.
(2) A certification mark may be used on a product manufactured during the period of certification referred to in Article 18 (6) or the period extended pursuant to paragraph (7) of the aforesaid Article, and on packaging, containers, advertising materials, etc. of such product only.
(3) In addition to matters prescribed in paragraphs (1) and (2), necessary matters concerning methods of indicating and using certification marks shall be prescribed by Ordinance of the Ministry of Health and Welfare.
[This Article Wholly Amended by Presidential Decree No. 26504, Sep. 1, 2015]
 Article 20 (Provision of Subsidies, etc. to Persons with Certified New Health Technology)
(1) The Minister of Health and Welfare may provide priority funding to a person with certified new health technology or who manufactures products using new health technology, for technological development for the promotion of a research and development project pursuant to Article 8 (4) of the Act. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(2) The Minister of Health and Welfare may request the heads of institutions managing the following Funds, etc. to subsidize persons with certified new health technology or who manufacture products using new health technology from the relevant Fund, etc.: <Amended by Presidential Decree No. 21835, Nov. 20, 2009; Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 22914, May 3, 2011; Presidential Decree No. 27205, May 31, 2016>
1. The Science and Technology Promotion Fund under Article 22 of the Framework Act on Science and Technology;
2. The Small and Medium Enterprise Startup and Promotion Fund under Article 63 of the Small and Medium Enterprises Promotion Act;
3. Funds for technological development provided by the Korea Development Bank under the Korea Development Bank Act or the Industrial Bank of Korea under the Industrial Bank of Korea Act;
4. Funds for new technology business of specialized credit finance companies registered as new technology business finance business pursuant to the Specialized Credit Finance Business Act or technology guarantee of the Korea Technology Guarantee Fund under the Korea Technology Finance Corporation Act;
5. Grants-in-aid for invention under Article 4 of the Invention Promotion Act;
6. Other special funds created by the Government to support technological development.
(3) The Minister of Health and Welfare may request any of the following to prioritize purchasing products manufactured using new health technology: <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
1. Government agencies or local governments;
2. Public enterprises, quasi-government agencies, and public institutions under the Act on the Management of Public Institutions;
3. Persons who receive financial support, such as contributions or subsidies, from the Government or local governments.
(4) The Minister of Health and Welfare may provide the following support to those with certified new health technology or who manufacture products using new health technology: <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
1. Technical guidance and support for the acquisition of Korean or foreign certification of quality;
2. Introduction or provision of overseas technical information, or provision of technical information retained without compensation;
3. Assistance with using research facilities and equipment.
 Article 20-2 (Corrective Recommendation and Order to Remove Certification Marks)
(1) Where a person with certified new health technology falls under any of the following as prescribed by the former part of Article 8-2 (4) of the Act, the Minister of Health and Welfare may recommend or order the person with certified new health technology (hereafter in this Article, referred to as "person with certified new health technology") under Article 8 (1) of the Act to remove a certification mark. In such cases, the person in receipt of a recommendation or order shall bear expenses incurred in removing a certification mark:
1. Where the person with certified new health technology uses a mark certifying new health technology after the expiry of certification referred to in Article 18 (6) or a period extended pursuant to paragraph (7) of the aforesaid Article;
2. Where the person with certified new health technology violates the method of using a mark certifying new health technology referred to in Article 19.
(2) Any person in receipt of a corrective recommendation or order under paragraph (1) shall notify the Minister of Health and Welfare as to whether he/she will comply with such recommendation, and where he/she fails to comply therewith, he/she shall submit to the Minister of Health and Welfare, grounds for non-compliance or the results of taking measures following such order (hereafter in this Article, referred to as "results of taking measures, etc."), within 20 days from the date he/she receives such recommendation or order.
(3) The Minister of Health and Welfare in receipt of the results of taking measures, etc., may conduct an on-site inspection to ascertain whether the results are authentic, and collect data, such as collection of products.
[This Article Newly Inserted by Presidential Decree No. 26504, Sep. 1, 2015]
 Article 21 (Revocation of Certification of New Health Technology)
(1) Where the Minister of Health and Welfare intends to revoke certification of new health technology pursuant to Article 9 (1) of the Act, he/she shall first state specific grounds for revocation to a person who has obtained certification to give him/her preliminary notice of revocation. <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 22914, May 3, 2011>
(2) Any person in receipt of preliminary notice of the revocation of certification pursuant to paragraph (1), may submit explanatory materials within the period classified as follows from the date he/she receives preliminary notice: <Amended by Presidential Decree No. 22914, May 3, 2011>
1. First preliminary notice: 20 days;
2. Second preliminary notice: 10 days (limited to where he/she fails to submit explanatory materials when he/she receives the first preliminary notice).
(3) The Minister of Health and Welfare shall determine whether to revoke the certification of new health technology after he/she examines and reviews explanatory materials submitted pursuant to paragraph (2). In such cases, where a person in receipt of preliminary notice of revocation pursuant to paragraph (1), fails to submit explanatory materials under paragraph (2), he/she shall be deemed to have acknowledged the ground for revocation. <Amended by Presidential Decree No. 22914, May 3, 2011>
(4) Where the Minister of Health and Welfare revokes certification, he/she shall immediately notify the relevant person and interested parties thereof, and post a notice of the revocation on the website of the Ministry of Health and Welfare and publicly notify the revocation in the Official Gazette or a daily newspaper. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(5) In addition to matters prescribed in paragraphs (1) through (4), necessary matters concerning the revocation of certification of new health technology shall be prescribed and publicly notified by the Minister of Health and Welfare. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 22 (Applications for Transfer of Industrial Property Rights, etc.)
(1) Any person who intends to acquire a State-owned industrial property right without compensation pursuant to Article 12 (1) of the Act shall submit an application to the Minister of Health and Welfare along with documents prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(2) Any person who intends to acquire research equipment, facilities, prototypes, etc. without compensation pursuant to Article 12 (1) of the Act shall submit an application to the Minister of Health and Welfare along with documents prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(3) Transfer referred to in paragraphs (1) and (2) shall be in accordance with an agreement between the Minister of Health and Welfare and the acquirer. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(4) Where the Minister of Health and Welfare intends to execute a transfer agreement under paragraph (3), he/she shall hold prior consultations with the Minister of Strategy and Finance regarding industrial property rights and with the Administrator of the Public Procurement Service regarding research equipment, facilities, and prototypes. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 23 (Collection, Use, etc. of Technology Licensing Royalties)
(1) A technology licensing royalty referred to in Article 14 of the Act shall be an amount stipulated in an agreement referred to in Article 5 within the limits equivalent to the amount of contributions made by the Minister of Health and Welfare pursuant to Article 5 (4) of the Act. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(2) The Minister of Health and Welfare may allow licensees to pay technology licensing royalties referred to in paragraph (1) in equal installments for a fixed period, as stipulated in an agreement referred to in Article 5, and he/she may grant reductions in the specific amount of technology licensing royalties to those who pay technology licensing royalties in lump sum or in advance. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(3) Where the Minister of Health and Welfare intends to use technology licensing royalties pursuant to Article 14 (2) of the Act, he/she shall formulate a plan for the use of technology licensing royalties and such plan shall be reviewed by the Committee. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(4) In addition to matters prescribed in paragraphs (1) through (3), detailed matters concerning the collection, management, and use of technology licensing royalties, shall be prescribed and announced by the Minister of Health and Welfare. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 24 (Registration of Establishment of National Evidence-Based Healthcare Collaborating Agency)
Matters concerning the registration of establishment referred to in Article 19 (3) of the Act shall be as follows: <Amended by Presidential Decree No. 23615, Feb. 3, 2012>
1. Objectives;
2. Name;
3. Location of the principal office;
4. Names and addresses of executive officers;
5. Total assets.
 Article 25 (Affairs, etc.)
(1) "Affairs prescribed by Presidential Decree" in subparagraph 7 of Article 21 of the Act means the following: <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 23615, Feb. 3, 2012; Presidential Decree No. 25123, Jan. 28, 2014>
1. Analysis of clinical effectiveness and technology on pharmaceutical drugs, medical devices, and health and medical technology;
2. Cooperation with Korean and overseas health and medical research institutions;
3. Other affairs deemed necessary by the Minister of Health and Welfare to improve efficiency of health and medical technology and products.
(2) The business year of the National Evidence-based Healthcare Collaborating Agency shall coincide with the fiscal year prescribed by the National Finance Act.
 Article 26 (Submission, etc. of Requests for Appropriation of Government Contributions)
The president of the National Evidence-based Healthcare Collaborating Agency shall submit a request for appropriation of Government contributions to the Minister of Health and Welfare pursuant to Article 25 (3) of the Act, along with the following documents, by no later than eight months before the fiscal year specified in Article 2 of the National Finance Act: <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 23615, Feb. 3, 2012>
1. Business plan for the fiscal year;
2. Written income forecast and forecast balance sheet for the fiscal year;
3. Other documents necessary to substantiate the request for appropriation of Government contributions.
 Article 27 (Applications for Payment of Government Contributions)
Where the president of the National Evidence-based Healthcare Collaborating Agency intends to receive Government contributions, he/she shall submit an application to the Minister of Health and Welfare, along with a plan for the implementation of the yearly appropriation of Government contributions, by no later than 30 days prior to the scheduled date of payment of contributions. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 28 (Payment and Use of Government Contributions)
(1) Where the Minister of Health and Welfare deems a plan for the implementation of the yearly appropriation of Government contributions submitted under Article 27 reasonable, he/she shall pay contributions. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(2) Where the Minister of Health and Welfare decides to pay Government contributions, he/she shall notify the president of the National Evidence-based Healthcare Collaborating Agency of the details thereof in writing. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(3) The president of the National Evidence-based Healthcare Collaborating Agency in receipt of an appropriation of Government contributions pursuant to Article 27, shall establish a separate account to manage such appropriation.
(4) Where an alteration is made to the implementation of an appropriation in a plan for the implementation of the yearly appropriation submitted under Article 27, the president of the National Evidence-based Healthcare Collaborating Agency shall pre-report the details of alteration to be made and grounds for alteration to the Minister of Health and Welfare and obtain his/her approval. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 29 (Statement of Accounts)
The president of the National Evidence-based Healthcare Collaborating Agency shall submit a revenue budget and expenditure budget to the Minister of Health and Welfare, along with the following documents, within three months from the end of the fiscal year prescribed by the National Finance Act: <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
1. Income statement and balance sheet for the fiscal year;
2. Comparative table of a business plan for the fiscal year and the result of the execution therof;
3. Written opinion from a certified public accountant designated by the Minister of Health and Welfare and a written opinion from an auditor of the National Evidence-based Healthcare Collaborating Agency;
4. Other documents that may verify the details of the settlement of accounts.
 Article 30 (Application Mutatis Mutandis of Provisions for Payment of Contributions, etc.)
Where the president of the National Evidence-based Healthcare Collaborating Agency receives Government contributions from central administrative agencies other than the Minister of Health and Welfare, the provisions of Articles 26 through 29 shall apply mutatis mutandis to the submission, etc. of requests for appropriation of Government contributions. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 31 (Handling of Surpluses)
Where a surplus accrues upon settlement of accounts for the fiscal year, the president of the National Evidence-based Healthcare Collaborating Agency shall appropriate the surplus to make up for any loss brought forward and carry forward the remainder to the following year.
 Article 32 (Institutions subject to Collection of Information)
"Public institutions prescribed by Presidential Decree" in the former part of Article 26 (1) of the Act means the following institutions: <Amended by Presidential Decree No. 21461, Apr. 30, 2009; Presidential Decree No. 22977, Jun. 24, 2011; Presidential Decree No. 23615, Feb. 3, 2012; Presidential Decree No. 24077, Aug. 31, 2012; Presidential Decree No. 25649, Oct. 8, 2014>
1. National Health Insurance Service established under Article 13 of the National Health Insurance Act;
2. Health Insurance Review and Assessment Service established under Article 62 of the National Health Insurance Act;
3. Korea Health Industry Development Institute established under the Korea Health Industry Development Institute Act;
4. Research institutes and the National Research Council for Economics, Humanities and Social Sciences established under the Act on the Establishment, Operation and Fostering of Government-Funded Research Institutes, Etc;
6. Basic Research Promotion Council established under Article 15-2 of the Framework Act on Science and Technology;
7. Korea Institute of Science and Technology Evaluation and Planning established under Article 20 of the Framework Act on Science and Technology;
8. Korea Evaluation Institute of Industrial Technology established under Article 39 of the Industrial Technology Innovation Promotion Act;
9. Korea Institute of Radiological and Medical Sciences established under Article 39 of the Radiation and Radioisotope Use Promotion Act;
10. National Cancer Center established under Article 27 of the Cancer Control Act;
11. National university-affiliated hospitals established under the Act on the Establishment of National University-Affiliated Hospitals;
12. National university-affiliated dental hospitals established under the Act on the Establishment of National University-Affiliated Dental Hospitals;
13. Seoul National University Hospital established under the Establishment of Seoul National University Hospital Act;
14. Seoul National University Dental Hospital established under the Establishment of Seoul National University Dental Hospital Act;
15. National Medical Center established under the Act on Establishing and Administrating the National Medical Center;
16. Local medical centers established under the Act on the Establishment and Management of Local Medical Centers.
 Article 32-2 (Handling of Sensitive Information, Personally Identifiable Information, etc.)
Where essential to conduct the following affairs, the president of the National Evidence-based Healthcare Collaborating Agency may handle data including information on health referred to in Article 23 of the Personal Information Protection Act, resident registration numbers, passport numbers, or alien registration numbers, referred to in subparagraph 1, 2, or 4 of Article 19 of the Enforcement Decree of the aforesaid Act:
1. Affairs concerning health and medical technology and products manufactured using health and medical technology under Article 21 of the Act;
2. Affairs concerning the appointment of executives under Article 23 of the Act;
3. Affairs concerning the integration and analysis of research data under Article 26 (3) of the Act.
[This Article Newly Inserted by Presidential Decree No. 25649, Oct. 8, 2014]
 Article 33 (Guidelines for Imposition of Administrative Fines)
Guidelines for imposition of administrative fines referred to in Article 30 of the Act shall be as specified in attached Table 2.
[This Article Newly Inserted by Presidential Decree No. 23615, Feb. 3, 2012]
ADDENDA
Article 1 (Enforcement Date)
This Decree shall enter into force on September 29, 2008.
Article 2 (Transitional Measures concerning Committee Members)
Committee members commissioned pursuant to the former provisions as at the time this Decree enters into force shall be deemed commissioned pursuant to this Decree, and the term of office of members shall be reckoned from the date they are commissioned pursuant to the former provisions.
ADDENDA <Presidential Decree No. 21461, Apr. 30, 2009>
Article 1 (Enforcement Date)
This Decree shall enter into force on May 1, 2009.
Article 2 Omitted.
ADDENDA <Presidential Decree No. 21835, Nov. 20, 2009>
Article 1 (Enforcement Date)
This Decree shall enter into force on November 22, 2009.
Articles 2 and 3 Omitted.
ADDENDA <Presidential Decree No. 22003, Jan. 27, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on February 1, 2010.
Articles 2 through 5 Omitted.
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on March 19, 2010. (Proviso Omitted.)
Article 2 Omitted.
ADDENDA <Presidential Decree No. 22163, May 18, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Applicability to Matters Agreed)
The amended provisions of Article 5 (2) shall begin to apply from the first agreement concluded after this Decree enters into force.
ADDENDUM <Presidential Decree No. 22914, May 3, 2011>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 22977, Jun. 24, 2011>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 and 3 Omitted.
ADDENDUM <Presidential Decree No. 23615, Feb. 3, 2012>
This Decree shall enter into force on February 5, 2012.
ADDENDA <Presidential Decree No. 24077, Aug. 31, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on September 1, 2012. (Proviso Omitted.)
Articles 2 through 9 Omitted.
ADDENDUM <Presidential Decree No. 25123, Jan. 28, 2014>
This Decree shall enter into force on January 31, 2014.
ADDENDUM <Presidential Decree No. 25649, Oct. 8, 2014>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 26092, Feb. 10, 2015>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Transitional Measures concerning Administrative Fines)
Where guidelines for the imposition of administrative fines apply to offenses committed before this Decree enters into force, the former provisions shall apply to such offenses, notwithstanding the amended provisions of subparagraph 2 of attached Table 2.
ADDENDUM <Presidential Decree No. 26504, Sep. 1, 2015>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 27129, May 10, 2016>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 27205, May 31, 2016>
Article 1 (Enforcement Date)
This Decree shall enter into force on September 30, 2016. (Proviso Omitted.)
Articles 2 and 3 Omitted.
ADDENDA <Presidential Decree No. 27506, Sep. 22, 2016>
Article 1 (Enforcement Date)
This Decree shall enter into force on September 23, 2016.
Articles 2 through 4 Omitted.