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ENFORCEMENT RULES OF THE HEALTH AND MEDICAL SERVICE TECHNOLOGY PROMOTION ACT

Wholly Amended by Rule No. 67, Sep. 29, 2008

Amended by Rule No. 1, Mar. 19, 2010

Rule No. 11, jun. 1, 2010

Rule No. 53, May 6, 2011

Rule No. 107, Feb. 9, 2012

Rule No. 185, Mar. 23, 2013

Rule No. 221, Dec. 3, 2013

Rule No. 254, Aug. 6, 2014

Rule No. 283, Jan. 5, 2015

Rule No. 351, Sep. 2, 2015

Rule No. 490, Mar. 28, 2017

Rule No. 556, Feb. 13, 2018

 Article 1 (Purpose)
The purpose of this Rule is to prescribe matters delegated by the Health and Medical Service Technology Promotion Act and the Enforcement Decree of the same Act and matters necessary for the enforcement thereof.
 Article 2 (Research Tasks)
(1) Research tasks referred to in Article 4 (2) of the Enforcement Decree of the Health and Medical Service Technology Promotion Act (hereinafter referred to as the "Decree") shall be selected by classifying them into tasks by public invitation and designated tasks.
(2) A task by public invitation shall be selected through open recruitment, while a designated task shall be identified and planned by the Minister of Health and Welfare and performed by an institution in charge of relevant research (hereinafter referred to as "institution in charge of research") designated from among institutions falling under the subparagraphs of Article 5 (2) of the Health and Medical Service Technology Promotion Act (hereinafter referred to as the "Act") or selected through open recruitment. <Amended by Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010>
 Article 3 (Formulation, etc. of Annual Action Plans)
(1) The Minister of Health and Welfare shall require the head of an institution specialized in research and development projects referred to in Article 7 (1) of the Act (hereinafter referred to as "specialized institution") to formulate an annual action plan for research and development projects for health and medical service technology referred to in Article 5 (1) of the Act (hereinafter referred to as "research and development projects") and to submit the plan within the period determined by the Minister of Health and Welfare. <Amended by Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010; Ordinance of the Ministry of Health and Welfare No. 221, Dec. 3, 2013>
(2) The Minister of Health and Welfare shall determine and publicly notify the annual action plan for research and development projects submitted by the head of the specialized institution, within two months after receipt thereof. <Amended by Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010; Ordinance of the Ministry of Health and Welfare No. 221, Dec. 3, 2013>
 Article 4 (Participation in Research and Development Projects)
A person who intends to participate in a research and development project shall apply to participate in accordance with pubic notice given under Article 3 (2).
 Article 5 (Organization for Research and Development Projects)
In order to efficiently perform business referred to in Article 3 (1) and Article 7 (1) 2 and 3 of the Act, the head of a specialized institution shall have both a separate organizational division for affairs relating to the planning, management, etc., of research and development projects and an organization for evaluating research and development projects, within such institution. <Amended by Ordinance of the Ministry of Health and Welfare No. 221, Dec. 3, 2013>
 Article 5-2 (Preparation, etc. of System for Classification of Health and Medical Service Technology)
(1) Where the Minister of Health and Welfare prepares the system for classification of health and medical service technology referred to in Article 7-2 (1) of the Act (hereinafter referred to as "classification system"), he/she shall link it to the National Standard Classification System for Science and Technology referred to in Article 27 (1) of the Framework Act on Science and Technology.
(2) The Minister of Health and Welfare shall prepare a draft classification system; hear opinions of relevant institutions, organizations, academic societies, etc. thereon; and then determine the classification system, subject to deliberation by the policy deliberative committee for health and medical service technology referred to in Article 6 (1) of the Act.
(3) The Minister of Health and Welfare shall revise and supplement the classification system every three years, taking into account international trends in the health and medical services technology sector, the emergence of new technology, etc.
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 221, Dec. 3, 2013]
 Article 6 (Application, etc. for Certification of New Exceptional Technology)
(1) The Minister of Health and Welfare shall entrust the Korea Health Industry Development Institute under the Korea Health Industry Development Institute Act (hereinafter referred to as the "Korea Health Industry Development Institute") with the affairs of certification of new exceptional technology, pursuant to Article 8 (7) of the Act. <Amended by Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010; Ordinance of the Ministry of Health and Welfare No. 351, Sep. 2, 2015>
(2) A person who intends to obtain certification of new exceptional technology shall submit an application for certification of new exceptional technology in attached Form 1, to the President of the Korea Health Industry Development Institute, along with the following documents:
1. A description of technology and product in attached Form 2;
2. A copy of the business registration certificate and a copy of the factory registration certificate, if the business and a factory are registered;
3. A certificate issued by the International Organization for Standardization (ISO), or a description of the quality management system for the applied product;
4. Relevant documents, if the applicant holds any industrial property right to new exceptional technology;
5. Data on records of certification or a product test report, if the relevant technology is certified or tested by any domestic or foreign authorized institution;
6. Relevant documents, if the applicant has engaged in any joint research or received any technology transfer;
7. Relevant documents, if the applicant has received a report on prior art search from any authorized institution.
(3) Upon receipt of an application referred to in paragraph (2), the President of the Korea Health Industry Development Institute shall examine application documents and may request the applicant to supplement any of such documents if the details of the documents are insufficient or need to be supplemented.
(4) A person who intends to file an objection pursuant to Article 18 (5) of the Decree shall submit an application for objection to new exceptional technology in attached Form 3, to the President of the Korea Health Industry Development Institute, along with evidentiary documents.
(5) The President of the Korea Health Industry Development Institute shall determine a certification period not exceeding five years pursuant to Article 18 (6) of the Decree, taking into account the potential of sustainable development, commercialization, etc. of relevant technology. <Amended by Ordinance of the Ministry of Health and Welfare No. 53, May 6, 2011; Ordinance of the Ministry of Health and Welfare No. 556, Feb. 13, 2018>
 Article 7 (Issuance, etc. of Certificate of New Exceptional Technology)
(1) The Minister of Health and Welfare shall issue the applicant a certificate of new exceptional technology in attached Form 4, pursuant to Article 8 (3) of the Act, for the technology conclusively determined as new technology, following an application for objection filed under Article 6 (4). <Amended by Ordinance of the Ministry of Health and Welfare No. 53, May 6, 2011>
(2) Where the President of the Korea Health Industry Development Institute certifies new exceptional technology pursuant to Article 8 (3) of the Act, he/she shall publish such fact on the web-site of the Korea Health Industry Development Institute and publicly notify such fact in the Official Gazette or in a daily newspaper having nationwide distribution pursuant to the Act on the Guarantee of Freedom and Functions of Newspapers, Etc.
(3) Where a person, who has been issued a certificate of new exceptional technology under paragraph (1), loses the certificate or where the certificate is too worn out, he/she may apply for re-issuance of the certificate of new exceptional technology by completing an application for re-issuance in attached Form 5 and attaching the defaced certificate of new exceptional technology thereto.
(4) Where any modification has been made to any entry in a certificate of new exceptional technology or a legal relationship regarding the new exceptional technology has been changed due to transfer, a merger, etc., the relevant person, who has been issued the certificate of new exceptional technology under paragraph (1), shall submit an application for modification in attached Form 6 to the President of the Korea Health Industry Development Institute, along with evidentiary materials and the certificate of new exceptional technology.
 Article 8 (Application for Extension of Certification Period)
(1) A person who intends to obtain the extension of a certification period for new exceptional technology pursuant to Article 18 (7) of the Decree, shall submit an application for extension of the period in attached Form 7 accompanied by evidentiary documents, to the President of the Korea Health Industry Development Institute, two months before the certification period expires. <Amended by Ordinance of the Ministry of Health and Welfare No. 11, Jun. 1, 2010>
(2) Technology eligible for the application for the extension of the certification period under paragraph (1), shall be limited to either technology which has yet to be commercialized as at the end of the certification period or technology for which one year has yet to elapse since its commercialization, and the certification period may be extended only once. <Amended by Ordinance of the Ministry of Health and Welfare No. 11, Jun. 1, 2010>
(3) Upon receipt of an application for extension of the certification period for new exceptional technology filed pursuant to paragraph (1), the President of the Korea Health Industry Development Institute shall examine the following matters to determine whether to extend the period and as to how long it will be extended:
1. The status of the development of technology the same as or similar to the relevant new exceptional technology as at the time the application for extension of the certification period is filed;
2. Whether it is possible to commercialize the relevant technology if its certification period is extended, and timing for doing so.
 Article 9 Deleted. <by Ordinance of the Ministry of Health and Welfare No. 351, Sep. 2, 2015>
 Article 10 (Bearing Expenses for Examination and Evaluation)
(1) A person who files an application for certification of new exceptional technology shall partially reimburse expenses incurred in examining and evaluating the relevant technology to the President of the Korea Health Industry Development Institute pursuant to Article 8 (5) of the Act, either when he/she submits the application or within a given period.
(2) An amount to be paid pursuant to paragraph (1) shall be determined and publicly notified by the Minister of Health and Welfare. <Amended by Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010>
 Article 10-2 (Method of Using New Exceptional Technology Certification Mark)
(1) A person who has obtained certification of new exceptional technology may use the certification mark referred to in Article 19 (1) of the Decree for the relevant product, if the product is stated in the description of technology and product in attached Form 2 submitted when he/she applies for certification thereof.
(2) Notwithstanding paragraph (1), a person who has obtained certification of new exceptional technology may use the certification mark referred to in Article 19 (1) of the Decree for a product to which new exceptional technology is verified as having been applied pursuant to Article 10-3, even though the product is not stated in the description of technology and product in attached Form 2 submitted when he/she applies for certification thereof.
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 351, Sep. 2, 2015]
 Article 10-3 (Verification of Products to Which New Exceptional Technology Is Applied )
(1) A person who intends to have a product verified as a product to which new exceptional technology is applied shall submit an application for verification of a product to which new exceptional technology is applied in attached Form 7-2 to the President of the Korea Health Industry Development Institute, along with materials explaining or verifying that new exceptional technology has been applied to the product in question.
(2) The President of the Korea Health Industry Development Institute shall determine whether new exceptional technology has been applied to the product in question and give notice of his/her decision to the person who intends to have the product verified as a product to which new exceptional technology is applied within 15 days from the date of application under paragraph (2): Provided, That such notice may be given within 30 days from the date of application, in extenuating circumstances, such as where expert examination is required.
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 351, Sep. 2, 2015]
 Article 10-4 (Procedures for Reporting on Certification Mark)
(1) A person who uses a certification mark shall specify the details, records, etc. of the use of the certification mark in a report on records of use of new exceptional technology certification mark in attached Form 7-3 and submit the report to the President of the Korea Health Industry Development Institute by the end of January of the year following the year the certification mark was used, pursuant to Article 8-2 (3) of the Act.
(2) The President of the Korea Health Industry Development Institute shall report to the Minister of Health and Welfare on the details, records, etc. of the use of the certification mark submitted pursuant to paragraph (1), by the end of February of the year following the year the certification mark was used.
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 351, Sep. 2, 2015]
 Article 11 (Application for Transfer of Industrial Property Rights, etc.)
(1) A person who intends to acquire a State-owned industrial property right without compensation pursuant to Article 22 (1) of the Decree shall submit an application in attached Form 8, to the Minister of Health and Welfare, along with a copy of the relevant written research agreement and business plan. <Amended by Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010>
(2) A person who intends to acquire research equipment, facilities, prototypes, etc. without compensation pursuant to Article 22 (2) of the Decree shall submit an application in attached Form 9 to the Minister of Health and Welfare, along with a copy of the relevant written research agreement. <Amended by Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010>
 Article 12 (Standards for Designation of Research-Oriented Hospitals)
The standards for designating research-oriented hospitals referred to in Article 15 (1) of the Act (hereinafter referred to as "research-oriented hospitals") shall be as specified in attached Table 2.
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 107, Feb. 9, 2012]
 Article 13 (Procedures for Designation of Research-Oriented Hospitals)
(1) Where the Minister of Health and Welfare intends to designate research-oriented hospitals, he/she shall publicly notify a designation plan four months before the scheduled date of designation.
(2) The head of a medical institution who intends to obtain designation of a research-oriented hospital shall submit an application for designation of research-oriented hospital in attached Form 10 to the Minister of Health and Welfare, along with the following documents and relevant evidentiary materials, by the deadline specified in the designation plan for research-oriented hospitals publicly notified pursuant to paragraph (1): <Amended by Ordinance of the Ministry of Health and Welfare No. 185, Mar. 23, 2013; Ordinance of the Ministry of Health and Welfare No. 221, Dec. 3, 2013>
1. Status of research human resources, etc., in attached Form 11;
2. Status of research facilities in attached Form 12;
3. Status of research equipment in attached Form 13;
4. Research performance in attached Form 14;
5. A plan for operation of a research-oriented hospital in attached Form 15;
6. A medical institution certificate referred to in Article 64-5 (1) of the Enforcement Rule of the Medical Service Act (Provided, That in cases of a dental hospital or oriental medical hospital, a copy of a certificate of designation of a dental training hospital referred to in Article 5 (2) of the Detailed Regulations on the Training, Recognition of Qualifications, etc. of Dental Specialists, or a copy of a certificate of designation of an oriental medical training hospital referred to in Article 6 (2) of the Detailed Regulations on the Training, Recognition of Qualifications, etc. of Herb Doctors);
7. A copy of a certificate of designation of a clinical trial institution on medicines, etc. issued by the Minister of Food and Drug Safety, or a copy of a certificate of designation of a clinical trial institution referred to in Article 12-2 (5) of the Enforcement Rule of the Medical Devices Act;
8. Deleted. <by Ordinance of the Ministry of Health and Welfare No. 221, Dec. 3, 2013>
(3) Upon receipt of an application filed under paragraph (2), the Minister of Health and Welfare shall determine whether to designate the relevant medical institution as a research-oriented hospital and notify the applicant of his/her decision. In such cases, where the Minister of Health and Welfare designates the relevant medical institution as a research-oriented hospital, he/she shall issue the applicant a certificate of designation of research-oriented hospital in attached Form 16.
(4) Except as otherwise expressly provided for in paragraphs (1) through (3), matters necessary for the designation of research-oriented hospitals shall be determined and publicly notified by the Minister of Health and Welfare.
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 107, Feb. 9, 2012]
 Article 14 (Returning Certificate of Designation of Research-Oriented Hospital)
Where the designation of a research-oriented hospital is cancelled pursuant to Article 15-2 of the Act, the head of the relevant medical institution shall return the relevant certificate of designation of the research-oriented hospital issued pursuant to the latter part of Article 13 (3) to the Minister of Health and Welfare without delay.
[This Article Wholly Amended by Ordinance of the Ministry of Health and Welfare No. 221, Dec. 3, 2013]
 Article 15 (Re-Designation of Research-Oriented Hospitals)
Articles 12 through 14 shall apply mutatis mutandis to the standards and procedures for the re-designation of a research-oriented hospital referred to in Article 15 (4) of the Act. In such cases, the Minister of Health and Welfare shall evaluate as to whether the plan for operation of the research-oriented hospital referred to in Article 13 (2) 5 has been implemented.
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 107, Feb. 9, 2012]
 Article 16 (Outsourcing of Evaluation Affairs)
(1) The Minister of Health and Welfare may outsource the evaluation affairs referred to in Article 15 (3) of the Act, to any of the following institutions or organizations, pursuant to Article 15 (5) of the Act: <Amended by Ordinance of the Ministry of Health and Welfare No. 221, Dec. 3, 2013>
1. An institution specialized in research and development projects referred to in Article 7 (1) of the Act;
2. A non-profit corporation or special corporation with professional human resources and capabilities for the evaluation of research-oriented hospitals.
(2) The Minister of Health and Welfare may subsidize expenses incurred in performing the evaluation affairs, within budgetary limits, for an institution or organization to which such affairs have been outsourced pursuant to paragraph (1).
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 107, Feb. 9, 2012]
 Article 17 (Review of Regulation)
The Minister of Health and Welfare shall review the appropriateness of documents required to be attached when an application for certification of new exceptional technology is filed under Article 6, every two years from January 1, 2015 (referring to the period before January 1 of every second year), and shall take measures, such as making improvements.
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 283, Jan. 5, 2015]
ADDENDUM
This Rule shall enter into force on September 29, 2008.
ADDENDA <Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010>
Article 1 (Enforcement Decree)
This Rule shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 and 3 Omitted.
ADDENDUM <Ordinance of the Ministry of Health and Welfare No. 11, Jun. 1, 2010>
This Rule shall enter into force on the date of its promulgation.
ADDENDUM <Ordinance of the Ministry of Health and Welfare No. 53, May 6, 2011>
This Rule shall enter into force on the date of its promulgation.
ADDENDUM <Ordinance of the Ministry of Health and Welfare No. 107, Feb. 9, 2012>
This Rule shall enter into force on the date of its promulgation.
ADDENDA <Ordinance of the Ministry of Health and Welfare No. 185, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Rule shall enter into force on the date of its promulgation.
Articles 2 through 5 Omitted.
ADDENDUM <Ordinance of the Ministry of Health and Welfare No. 221, Dec. 3, 2013>
This Rule shall enter into force on the date of its promulgation: Provided, That the amended provisions of Article 5-2 shall enter into force on January 31, 2014.
ADDENDUM <Ordinance of the Ministry of Health and Welfare No. 254, Aug. 6, 2014>
This Rule shall enter into force on the date of its promulgation.
ADDENDUM <Ordinance of the Ministry of Health and Welfare No. 283, Jan. 5, 2015>
This Rule shall enter into force on the date of its promulgation..
ADDENDUM <Ordinance of the Ministry of Health and Welfare No. 351, Sep. 2, 2015>
This Rule shall enter into force on the date of its promulgation.
ADDENDA <Ordinance of the Ministry of Health and Welfare No. 490, Mar. 28, 2017>
Article 1 (Enforcement Date)
This Rule shall enter into force on March 30, 2017.
Article 2 Omitted.
Article 3 (Applicability Following Amendment of the Enforcement Rule of the Health and Medical Service Technology Promotion Act)
The amended provisions of attached Form 2 of the Enforcement Rule of the Health and Medical Service Technology Promotion Act shall also apply where procedures for certifying new exceptional technology are underway as at the time this Rule enters into force.
ADDENDUM <Ordinance of the Ministry of Health and Welfare No. 556, Feb. 13, 2018>
This Rule shall enter into force on the date of its promulgation.