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ENFORCEMENT DECREE OF THE SPECIAL ACT ON THE DESIGNATION AND SUPPORT OF HIGH-TECH MEDICAL COMPLEXES

Presidential Decree No. 20869, jun. 25, 2008

Amended by Presidential Decree No. 21227, Dec. 31, 2008

Presidential Decree No. 21835, Nov. 20, 2009

Presidential Decree No. 22075, Mar. 15, 2010

Presidential Decree No. 24454, Mar. 23, 2013

Presidential Decree No. 27129, May 10, 2016

Presidential Decree No. 27316, Jul. 6, 2016

Presidential Decree No. 28211, Jul. 26, 2017

 Article 1 (Purpose)
The purpose of this Decree is to prescribe matters delegated by the Special Act on the Designation and Support of High-Tech Medical Complexes and matters necessary for the enforcement thereof.
 Article 2 (Standards for Institutes for Research and Development of Medical Services)
(1) Standards for the research personnel and facilities of an institute for research and development of medical services as defined in subparagraph 6 of Article 2 of the Special Act on the Designation and Support of High-Tech Medical Complexes (hereinafter referred to as "Act") shall be as follows:
1. An institute for research and development of medical services shall at all times have three research personnel (one person in cases of a venture business as defined in Article 2 of the Act on Special Measures for the Promotion of Venture Businesses) who directly conduct medical research and development and do not concurrently engage in other duties, such as sales or business, aside from the duties of medical research and development;
2. An institute for research and development of medical services shall have the following facilities to independently conduct medical research and development:
(a) At least one laboratory;
(b) Research equipment that research personnel may readily use, such as experimental apparatus and electronic data storage media;
(c) Ancillary facilities, such as air purifying and heating and cooling equipment.
(2) Detailed standards for the research personnel and facilities of an institute for research and development of medical services under paragraph (1) shall be determined and publicly announced by the Minister of Health and Welfare in consideration of the kinds of institutes for research and development of medical services, details, characteristics of medical research and development and other factors. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 3 (Contents of Plans to Develop High-Tech Medical Complexes)
"Matters specified by Presidential Decree" in Article 4 (3) 7 of the Act means any of the following:
1. Plans to cooperate with institutes for research and development of medical services in Korea and overseas;
2. Matters deemed necessary by the committee on high-tech medical complexes established under Article 27 of the Act (hereinafter referred to as "committee on high-tech medical complexes").
 Article 4 (Requirements for Site Selection for High-Tech Medical Complexes)
"Matters specified by Presidential Decree" in Article 5 (2) 6 of the Act means impact on the balanced development of the National Land.
 Article 5 (Detailed Standards for Site Selection)
(1) Standards for outstanding researchers, institutes for research and development of medical services and medical institutions referred to in Article 5 (3) of the Act are as follows:
1. Outstanding researchers: A researcher having abundant experience and specialized knowledge in medical research and development, such as publishing research papers on medical research and development in Korea and overseas or participating in medical research and development projects;
2. Outstanding institutes for research and development of medical services: An institute for research and development of medical services having a track record of conducting medical research and development, such as a high ratio of medical research and development funds to total sales, or holding Korean or foreign patents on medical research and development;
3. Outstanding medical institutions: A medical institution having a track record of performing clinical tests entrusted by Korean or foreign enterprises, etc.
(2) Detailed standards to qualify for invitation and settlement, the level of clustering and connectivity of outstanding institutes for research and development of medical services, etc. referred to in Article 5 (3) of the Act are as follows:
1. Feasibility for invitation and settlement: That conditions for settlement, such as dwelling, medical services, education, environment, culture and transportation with which outstanding researchers and institutes for research and development of medical services under paragraph (1) 1 and 2 can be invited, shall be met, or that the improvement of conditions for settlement while a high-tech medical complex is being developed shall be highly feasible;
2. Level of clustering of outstanding institutes for research and development of medical services: That there shall be many institutes for research and development of medical services and outstanding medical institutions in an area specified by the committee on high-tech medical complexes, including places prearranged for high-tech medical complexes;
3. Degree of connectivity with outstanding institutes for research and development of medical services: That there shall be a sound track record of conducting research and development, research activities, etc. through cooperation among research and development institutes of medical services in Korea and overseas or exchanges therewith, such as a large number of concluded agreements;
4. Details of support by local governments: That there shall be a high level of financial and tax assistance by the Special Metropolitan City, Metropolitan Cities, Dos and Special Self-Governing Province to the institutes for research and development of medical services and support institutions for research and development of medical services, that take occupancy in a high-tech medical complex, with a high degree of support to activate the promotion of medical research and development;
5. Availability of sites: That sites are available and are efficient in light of regulations on the use of land, price of land, etc.;
6. Impact on the balanced development of the National Land: That there shall be substantial impact on the balanced development of the capital area and other areas, and large cities and small and medium-sized cities.
(3) Matters necessary for the specific scope of detailed standards for the site selection of high-tech medical complexes under paragraphs (1) and (2), evaluation thereof and other matters shall be determined by the Minister of Health and Welfare after deliberation by the committee on high-tech medical complexes. <Amended by Presidential Decree No. 21227, Dec. 31, 2008; Presidential Decree No. 22075, Mar. 15, 2010>
 Article 6 (Public Notification of Designation of High-Tech Medical Complexes or Cancellation thereof)
(1) If the site for a high-tech medical complex is selected pursuant to Article 6 (1) of the Act, the Minister of Health and Welfare shall publicly notify the details of designation of the high-tech medical complex, including following matters: <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
1. Name, location and size of the high-tech medical complex;
2. Purpose of designating the high-tech medical complex;
3. Main facilities to be established in the high-tech medical complex;
4. Other matters deemed necessary by the committee on high-tech medical complexes.
(2) If the Minister of Health and Welfare fully or partially cancel the designation of a high-tech medical complex pursuant to Article 8 (2) of the Act, he/she shall publicly notify the grounds for cancellation and the date of cancellation (including changes among the details publicly notified under paragraph (1) if the designation is partially cancelled). <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 7 (Submission of Plans to Advance High-Tech Medical Complexes)
Every three years, the head of an operating agency referred to in Article 10 (1) of the Act shall submit a plan to carry out matters under his/her jurisdiction, that are necessary for advancing a high-tech medical complex by not later than three months before the commencement of the fiscal year as defined in Article 2 of the National Finance Act. <Amended by Presidential Decree No. 21227, Dec. 31, 2008; Presidential Decree No. 22075, Mar. 15, 2010>
 Article 8 (Matters to be Included in Comprehensive Plans)
"Matters specified by Presidential Decree" in Article 10 (4) 8 of the Act means the following: <Amended by Presidential Decree No. 21227, Dec. 31, 2008>
1. Matters concerning facilitating investment in medical research and development from Korea and overseas;
2. Matters concerning training human resources, such as research personnel and human resources for technical training;
3. Other matters deemed necessary by the committee on high-tech medical complexes.
 Article 9 (Other Support Institutions for Research and Development of Medical Services)
"Institution specified by Presidential Decree" in Article 11 (1) 3 (d) of the Act means any of the following: <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
1. An institution managing organic substances, chemical compounds, etc. necessary for medical research and development;
2. An institution recognized by the Minister of Health and Welfare, which facilitates supply of information on Korean or foreign patents, transaction of technology, development of designs, etc. to commercialize medical research and development and the outcomes thereof.
 Article 10 (Standards for Granting Subsidies to Support Institutions for Research and Development of Medical Services)
Pursuant to Article 11 (3) of the Act, the State and local governments may grant graded subsidies to support institutions for research and development of medical services in consideration of the following: <Amended by Presidential Decree No. 21227, Dec. 31, 2008>
1. Level of providing medical research services: Level of quality and price of medical research and development services provided by a support institution for research and development of medical services to institutes for research and development of medical services;
2. Degree of improvement in research outcomes: Degree of facilitating medical research and development drawn as a result of medical research and development services provided by a support institution for research and development of medical services;
3. Efficiency in organizational management: Findings of evaluation of management performance, invitation of excellent human resources, training of specialized human resources and outcomes from development of new medical research and technology by a support institution for research and development of medical services.
 Article 11 (Those Eligible for Loans from Fund for Development of Industrial Infrastructure)
(1) Those eligible for a loan from the Fund for industrial infrastructural development under Article 13 (1) of the Act are as follows:
1. Medical research and development concerning medicines and medical equipment conducted by institutes for research and development of medical services and support institutions for research and development of medical services that have taken occupancy in a high-tech medical complex and support projects directly related thereto;
2. Medical research and development conducted by a medical institution designated pursuant to Article 21 (1) of the Act.
(2) In either of the following circumstances, the principal and interest of a loan can be fully or partially exempted or reduced pursuant to Article 13 (2) of the Act:
1. Where, as a result of the implementation of a medical research and development project, the project is determined to be economically infeasible or continuing medical research is deemed impracticable;
2. Where fully or partially repaying the principal and interest of a loan is impossible not for managerial reasons but for inevitable ones, such as a sudden change in economic circumstances in Korea and overseas, in the process of performing a medical research and development project.
(3) Except as otherwise expressly provided for in paragraphs (1) and (2), matters necessary for the conditions and repayment of loans under Article 13 (3) of the Act and other matters shall be governed by the Fund Management Guidelines approved by the Administrator of the Small and Medium Business Administration pursuant to Article 66 of the Enforcement Decree of the Small and Medium Enterprises Promotion Act. <Amended by Presidential Decree No. 21835, Nov. 20, 2009>
 Article 12 (Calculation of Charges for Commercial Use or Loan of the State-owned or Public Property, Charges on Profit therefrom, etc.)
Charges or rents for commercial use or lease of State or public property under Article 18 (4) of the Act shall be, per annum, 10/1,000 of the assessed price of the relevant State or public property under the State Property Act and the Public Property and Commodity Management Act.
 Article 13 (Methods of Paying Price for Purchase of State or Public Property)
(1) The due date for paying the purchase price of State or public property under Article 18 (5) of the Act may be extended within one year, or such purchase price may be paid in installments within 20 years.
(2) Where the due date for payment is extended or installment payments are made pursuant to paragraph (1), interest on the purchase price shall not exceed 4/1,000 per annum.
 Article 14 (Exceptions to Period, etc. of Stay of Foreigners)
(1) The upper limit on the period of stay that can be granted at one time for the status of stay corresponding to professorship visa (E-1), research visa (E-3), technology transfer visa (E-4), professional employment visa (E-5), special occupation visa (E-7), trade management visa (D-9) and family visitation visa (F-1) pursuant to Article 20 of the Act shall be five years.
(2) A person who intends to obtain a visa pursuant to paragraph (1) shall obtain a written recommendation from the Minister of Health and Welfare pursuant to Article 7 (3) of the Enforcement Decree of the Immigration Control Act and submit it to the Minister of Justice. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
 Article 15 (Composition and Operation of Sub-Committee for High-Tech Medical Complexes)
(1) The sub-committee for high-tech medical complexes established under the National Bioethics Committee (hereinafter referred to as "sub-committee") prescribed by Article 25 (1) of the Act shall consist of up to seven members, including one chairperson from among the following persons: <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 28211, Jul. 26, 2017>
1. The Minister of Science and ICT, the Minister of Trade, Industry and Energy and the Minister of Health and Welfare;
2. Two of the members referred to in Article 8 (3) 2 of the Bioethics and Safety Act;
3. Two of the members referred to in Article 8 (3) 3 of the Bioethics and Safety Act.
(2) The chairperson of the sub-committee (hereafter referred to as "chairperson" in this Article) and its members shall be appointed or commissioned by the chairperson of the National Bioethics Committee prescribed by Article 7 of the Bioethics and Safety Act (hereinafter referred to as the “National Committee”). <Amended by Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 27129, May 10, 2016>
(3) The term of office of commissioned members shall be as prescribed in Article 8 (4) of the Bioethics and Safety Act. <Amended by Presidential Decree No. 24454, Mar. 23, 2013>
(4) The chairperson of the National Committee may dismiss a commissioned member of a sub-committee who falls under any of the following: <Newly Inserted by Presidential Decree No. 27129, May 10, 2016>
1. Where he/she becomes incapable of performing his/her duties due to a mental disorder;
2. Where he/she has committed any misdeed in connection with his/her duties;
3. Where he/she is deemed disqualified as a member due to neglect of duties, injury to dignity, or any other reason;
4. Where he/she voluntarily expresses the intention that it is impracticable to perform his/her duties.
(5) The chairperson shall represent the sub-committee and has general supervision and control of its affairs. <Amended by Presidential Decree No. 27129, May 10, 2016>
(6) Where the chairperson is unable to perform his/her duties due to extenuating circumstances, a member designated by the chairperson in advance shall act on behalf of the chairperson. <Amended by Presidential Decree No. 27129, May 10, 2016>
(7) The chairperson shall call a meeting of the sub-committee and preside over such meeting in any of the following circumstances: <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 27129, May 10, 2016>
1. If requested by the Minister of Health and Welfare or the chairperson;
2. If requested by at least three incumbent members of the sub-committee;
3. If deemed necessary by the chairperson of the National Committee.
(8) If the chairperson intends to call a meeting, he/she shall notify the members of the date and venue of the meeting, agenda, etc. by not later than seven days before the meeting: Provided, That he/she may notify the members of such matters by not later than the day before the day the meeting is to be held in extenuating circumstances. <Amended by Presidential Decree No. 27129, May 10, 2016>
(9) Meetings of the Committee shall be held with a majority of all incumbent members present and resolutions shall be passed with the affirmative vote of a majority of those present. <Amended by Presidential Decree No. 27129, May 10, 2016>
(10) Where deemed necessary for deliberation, the chairperson may request relevant agencies, organizations, etc. to submit data or opinions. <Amended by Presidential Decree No. 27129, May 10, 2016>
(11) Matters deliberated on by the sub-committee shall be reported to the National Committee. <Amended by Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 27129, May 10, 2016>
(12) An executive secretary shall be appointed to the sub-committee to handle the administrative affairs of the sub-committee. In such cases, the head of a support office established under Article 30 (5) of the Act (hereinafter referred to as "support office") shall become the executive secretary. <Amended by Presidential Decree No. 27129, May 10, 2016>
(13) Except as otherwise expressly provided for in this Decree, matters concerning the operation of the sub-committee shall be determined by the chairperson following resolution by the sub-committee. <Amended by Presidential Decree No. 27129, May 10, 2016>
 Article 16 (Matters to be Deliberated on by Institutional Bioethics Committee)
An Institutional bioethics committee prescribed by Article 25 (3) of the Act (hereinafter referred to as "institutional committee") shall deliberate on matters prescribed in the subparagraphs of Article 10 (3) of the Bioethics and Safety Act. <Amended by Presidential Decree No. 24454, Mar. 23, 2013>
 Article 17 (Composition and Operation of Institutional Committee)
(1) An institutional committee shall consist of up to five members, including one chairperson, and the following persons shall be included therein:
1. One employee of an institute for research and development of medical services;
2. A person working in the field of bioscience or medical science;
3. Two persons who are not working for an agency or organization in a high-tech medical complex.
(2) The chairperson of an institutional committee shall be elected by mutual vote from among its members, and its members shall be commissioned by the head of a medical institution designated by the Minister of Health and Welfare pursuant to Article 21 (1) of the Act. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(3) The term of office of the members shall be two years, which is renewable for only one further term.
(4) The chairperson shall represent the relevant institutional committee, and administer overall management of its affairs.
(5) If the chairperson is unable to perform his/her duties due to extenuating circumstances, a member designated by the chairperson in advance shall perform such duties on his/her behalf.
(6) The chairperson of an institutional committee shall call a meeting of the institutional committee and chair such meeting in any of the following circumstances: <Amended by Presidential Decree No. 24454, Mar. 23, 2013>
1. If requested by the head of an agency;
2. If requested by at least 1/3 of all incumbent members of the institutional committee;
3. If deemed necessary by the chairperson of the institutional committee.
(7) Where the research, development or use of bioscience and technology conducted in a high-tech medical complex seriously compromise or is likely to compromise bioethics or safety, the chairperson shall, without delay, call a meeting and report the results of the meeting to the Minister of Health and Welfare. <Amended by Presidential Decree No. 22075, Mar. 15, 2010>
(8) Meetings of an institutional committee shall be held with a majority of all incumbent members present and resolutions shall be passed with the affirmative vote of a majority of those present. In such cases, at least one member falling under paragraph (1) 3 shall attend the meeting.
(9) No member involved in the research, development or use of bioscience and technology to be deliberated on under Article 16 shall participate in deliberation on any agenda item regarding such research, development or use of bioscience and technology.
(10) Where deemed necessary for deliberation by an institutional committee, the chairperson may request relevant agencies, organizations, etc. to submit data or opinions.
(11) An institutional committee shall prepare and keep documents in which the list and qualifications of members and the meeting minutes of the institutional committee are recorded.
(12) Except as otherwise expressly provided for in this Decree, matters concerning the operation of an institutional committee shall be determined by the chairperson following resolution by the institutional committee.
 Article 17-2 (Installation of Production Facilities of Resident Research and Development Institute of Medical Service)
(1) “Small-scale production facilities prescribed by Presidential Decree” in Article 26-2 (1) of the Act means production facilities of which the sum of floor areas is 3,000 square meters or less.
(2) A resident research and development institute of medical services which intends to obtain approval for installation of production facilities under the former part of Article 26-2 (2) of the Act shall submit to the Minister of Health and Welfare an application for installment prescribed by Ordinance of the Ministry of Health and Welfare (including an electronic application form) with the following documents attached:
1. Detailed statement of production facilities and items produced;
2. Plan for production operation of items produced;
3. Other documents the Minister of Health and Welfare deems necessary including research performance of resident research and development institutes of medical service.
(3) When the Minister of Health and Welfare receives an application pursuant to paragraph (2), he/she shall decide whether to approve the application, giving consideration to the following, and inform the applicant of the decision:
1. Impact on invigoration of research and development of medical service;
2. Effect related to commercialization of research results;
3. Impact on development of technology for health and medical services or others.
(4) A person who intends to obtain approval for adding items produced or approval for change under the latter part of Article 26-2 (2) of the Act shall submit an application for approval for change (including an electronic application form) with attaching documents of changes (including electronic document) to the Minister of Health and Welfare. In such case, paragraph (3) shall mutatis mutandis to process of application for approval for change.
(5) Matters other than those specified in paragraphs (1) through (4) necessary for procedures and methods of approval for installation of production facilities and approval for change shall be determined by Ordinance of the Ministry of Health and Welfare.
[This Article Newly Inserted by Decree No. 27316, Jul. 6, 2016]
 Article 18 (Composition and Operation of Committee on High-Tech Medical Complexes)
(1) "Heads of appropriate central administrative agencies specified by Presidential Decree" in Article 28 (2) of the Act means the Minister of Strategy and Finance, the Minister of Science and ICT, the Minister of Justice, the Minister of Trade, Industry and Energy, the Minister of Health and Welfare and the Minister of Land, Infrastructure and Transport. <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 24454, Mar. 23, 2013; Presidential Decree No. 28211, Jul. 26, 2017>
(2) The term of office of the commissioned members under Article 28 (3) of the Act shall be two years, which is renewable for only one further term.
(3) The chairperson may dismiss a commissioned member under Article 28 (3) of the Act, if the member falls under any of the following: <Newly Inserted by Act No. 27129, May 10, 2016>
1. Where he/she becomes unable to perform his/her duties due to a mental disorder;
2. Where he/she commits any misdeed in connection with his/her duties;
3. Where he/she is deemed unqualified for a member due to delinquency of duties, injury to dignity, or any other reason;
4. Where he/she voluntarily expresses the intention that it is impracticable to perform his/her duties.
(4) The chairperson shall represent the committee on high-tech medical complexes, and administer the overall management of its affairs. <Amended by Act No. 27129, May 10, 2016>
(5) If the chairperson is unable to perform his/her duties due to extenuating circumstances, a member in the order prescribed in paragraph (1) shall perform such duties on his/her behalf. <Amended by Act No. 27129, May 10, 2016>
(6) If requested by at least 1/3 of the incumbent members of the committee on high-tech medical complexes or if deemed necessary by the chairperson, the chairperson shall call a meeting of the committee on high-tech medical complexes and chair such meeting. <Amended by Act No. 27129, May 10, 2016>
(7) If the chairperson intends to call a meeting, he/she shall notify members of the date and venue of the meeting, agenda, etc. in writing by not later than seven days before the meeting: Provided, That he/she may notify members of such matters by not later than the day before the day the meeting is to be held in extenuating circumstances. <Amended by Act No. 27129, May 10, 2016>
(8) A majority of the 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. <Amended by Act No. 27129, May. 10, 2016>
(9) Where necessary for deliberating on the following matters concerning the operation of a high-tech medical complex, a sub-committee consisting of six members, including three commissioned members of the committee on high-tech medical complexes may be operated. In such case, matters deliberated on by the sub-committee shall be reported to the committee on high-tech medical complexes: <Amended by Act No. 27129, May 10, 2016>
1. Matters concerning the support organization under Article 30 of the Act;
2. Civil complaints or clerical works in need of prompt handling;
3. Matters requested by the committee on high-tech medical complexes for prior deliberation.
(10) The head of a central administrative agency, other than an ex officio member under Article 28 (2) of the Act, may attend a meeting of the committee on high-tech medical complexes and make a remark. <Amended by Act No. 27129, May 10, 2016>
(11) Except as otherwise expressly provided for in this Decree, matters necessary for the composition of the committee on high-tech medical complexes and the composition and operation of the sub-committee shall be determined by the chairperson following resolution by the committee on high-tech medical complexes. <Amended by Act No. 27129, May 10, 2016>
 Article 19 (Allowances)
Members and private specialists who attend a meeting of the committee on high-tech medical complexes may be paid allowances within budgetary limits: Provided, That where a public official member attends a meeting of the committee in direction connection with his/her duties, no allowance shall be paid to him/her.
 Article 20 (Duties, etc. of Support Organization)
(1) "Works specified by Presidential Decree" in Article 30 (2) of the Act means the following:
1. Drafting, planning, examining, evaluating, inspecting, etc. agenda items submitted to the committee on high-tech medical complexes;
2. Legislative legal services concerning high-tech medical complexes;
3. Designation of, and support for, high-tech medical complexes;
4. Data research, publicity and international cooperation concerning high-tech medical complexes;
5. Other matters concerning the efficient management of high-tech medical complexes.
(2) The executive officers and employees of corporations or organizations dispatched to the support organization under Article 30 of the Act (hereinafter referred to as "support organization") may be paid allowances within budgetary limits.
(3) Except as otherwise expressly provide for in paragraphs (1) and (2), matters necessary for the composition and operation of the support organization shall be determined by the chairperson of the committee on high-tech medical complexes following resolution by the committee on high-tech medical complexes.
 Article 21 (Approval for Move-in and Change)
(1) A person who intends to obtain approval for move-in pursuant to Article 31 (1) of the Act shall submit to the Minister of Health and Welfare an application for approval for move-in (including an electronic application) with the following documents (including an electronic document) attached:
1. A project plan of research and development of medical service;
2. Detailed statement of research personnel and facilities under subparagraphs of Article 2 (1);
3. A plan for the use of the site to be moved in;
4. Other documents that the Minister of Health and Welfare deems necessary including research performance of an institute which has applied for approval for move-in.
(2) When the Minister of Health and Welfare receives an application for approval for move-in, he/she shall decide whether to approve the application and inform the applicant of the decision:
1. The purpose of move-in and the appropriateness of a plan for research and development of medical services;
2. Feasibility of plan for the use of the site to be moved in;
3. Impact on invigoration of high-tech medical complexes.
(3) A person who intends to obtain approval to change any of the following matters shall submit an application for approval for change prescribed by Ordinance of the Ministry of Health and Welfare (including an electronic application) with documents of details of the change attached to the Minister of Health and Welfare. In such case, subparagraph (2) shall mutatis mutandis to process of application of approval for change:
1. Change of the name or the representative of a research and development institute of medical services;
2. Change of location of the site for move-in;
3. Change 10/100 or more of the total area of the site for move-in;
4. Change of plan for the use of the site for move-in.
(4) Except matters prescribed by paragraphs (1) through (3), details necessary for procedures and methods of approval for move-in or change shall be determined by Ordinance of the Ministry of Health and Welfare.
[This Article Wholly Amended by Presidential Decree No. 27316, Jul. 6, 2016]
 Article 22 (Entrustment of Authority)
Pursuant to Article 32 (2) of the Act, the Minister of Health and Welfare shall entrust the following duties to the heads of support offices: <Amended by Presidential Decree No. 22075, Mar. 15, 2010; Presidential Decree No. 27316, Jul. 6, 2016>
1. Issuing recommendations for application for a visa under Article 14 (2);
2. Receiving documents concerning any of the following duties and notification of the results of handling such duties:
(a) Approval for installation or change of small-scale production facilities under Article 26-2 (2);
(b) Approval for move-in and change under Article 31 (1) and (2) of the Act;
(c) Cancellation of approval for move-in and holding of a hearing under Article 31 (3) of the Act.
ADDENDA
Article 1 (Enforcement Date)
This Decree shall enter into force on June 29, 2008.
Articles 2 (Transitional Measures concerning Submission of First Promotional Plan)
The head of an operating agency under Article 10 (1) of the Act shall prepare a promotional plan for matters falling under his/her jurisdiction pursuant to Article 7 and submit it to the Minister of Health, Welfare and Family Affairs by not later than September 30, 2010. <Amended by Presidential Decree No. 21227, Dec. 31, 2008>
ADDENDUM <Presidential Decree No. 21227, Dec. 31, 2008>
This Decree shall enter into force on the date of its promulgation.
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. 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. 24454, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 4 Omitted.
ADDENDUM <Presidential Decree No. 27129, May 10, 2016>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 27316, Jul. 6, 2016>
This Decree shall enter into force on the date of its promulgation: Provided, That the amended provisions of Article 17-2 and subparagraph 2 (a) of Article 22 shall enter into force on July 7, 2016.
ADDENDA <Presidential Decree No. 28211, Jul. 26, 2017>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation: Provided, That among Presidential Decrees amended pursuant to Article 8 of the Addenda, the amended parts of the Presidential Decrees promulgated before this Decree enters into force, but the enforcement dates of which have not arrived, shall enter into force on the dates the relevant Presidential Decrees enter into force, respectively.
Articles 2 through 8 Omitted.