ENFORCEMENT DECREE OF THE ACT SUPPORTING OF OVERSEAS EXPANSION OF MEDICAL SERVICES AND ATTRACTION OF INTERNATIONAL PATIENTS
Presidential Decree No. 27241, Jun. 21, 2016
Amended by Presidential Decree No. 29677, Apr. 2, 2019
Presidential Decree No. 29962, Jul. 9, 2019
Presidential Decree No. 30642, Apr. 28, 2020
Presidential Decree No. 30993, Sep. 8, 2020
Presidential Decree No. 33098, Dec. 20, 2022
Presidential Decree No. 34645, Jul. 2, 2024
The purpose of this Decree is to provide for the matters mandated by the Act on Support for Overseas Expansion of Healthcare System and Attraction of International Patients and those necessary for enforcing said Act.
Article 2 (Scope of Overseas Expansion of Medical Services) |
"Actions as prescribed by Presidential Decree" in subparagraph 1 (f) of Article 2 of the Act on Support for Overseas Expansion of Healthcare System and Attraction of International Patients (hereinafter referred to as the "Act") shall mean supporting or educating a medical institution or personnel in a foreign country on medical knowledge or technology.
Article 3 (Reporting on Overseas Expansion of Medical Services) |
(1) | A founder of a medical institution under Article 3 of the Medical Service Act who intends to file a report on overseas expansion of medical services pursuant to Article 4 (1) of the Act shall submit a written report on overseas expansion of medical services prescribed by Ministerial Decree of Health and Welfare to the Minister of Health and Welfare, along with the following documents: <Amended on Dec. 20, 2022> |
1. | Deleted; <Dec. 20, 2022> |
2. | Documents verifying overseas expansion of medical services as classified in accordance with the following subparagraphs: |
(a) | Overseas expansion of medical services pursuant to subparagraph 1 (a) of Article 2 of the Act: a duplicate of the document proving establishment operation of an overseas medical institution: Provided, That in cases of having established or acquired an overseas corporation to establish or operate an overseas medical institution, a duplicate of the document providing establishment or acquisition of the relevant overseas medical institution; |
(b) | Overseas expansion of medical services pursuant to subparagraph 1 (b) through (f) of Article 2 of the Act: a duplicate of an agreement concluded for the relevant overseas expansion of medical services; |
3. | A business operation plan for the overseas expansion of medical services as determined by the Minister of Health and Welfare; |
4. | A corporation’s articles of incorporation which specifies overseas expansion of medical services (applicable only to a corporation). |
(2) | A public official in charge of relevant affairs shall, upon receipt of a written report under paragraph (1), verify a permit certifying establishment of a medical institution or a certificate of report on establishment of a medical institution, through administrative data matching under Article 36 (1) of the Electronic Government Act: Provided, That where a reporter does not consent to the verification, the relevant documents shall be attached. <Added on Dec. 20, 2022> |
(3) | The report prescribed in paragraph (1) shall be filed within the period specified in the following subparagraphs: <Amended on Dec. 20, 2022> |
1. | Overseas expansion of medical services under subparagraph 1 (a) of Article 2 of the Act: Within 45 days from the date of receiving dispositions from the relevant foreign government, such as authorization or permission for the establishment or operation of a medical institution in the foreign country: Provided, That in cases of establishing or acquiring an overseas corporation to establish or operate an overseas medical institution, the report shall be filed within 45 days from the date of establishment or acquisition; |
2. | Overseas expansion of medical services under subparagraph 1 (b) through (f) of Article 2 of the Act: Within 45 days from the date of concluding a contract on the relevant overseas expansion of medical services. |
(4) | If there is any deficiency in the report filed pursuant to paragraph (1) or if it is deemed necessary to verify facts about such report, etc., the Minister of Health and Welfare may order supplementation thereof within a specified period of up to five days. <Amended on Dec. 20, 2022> |
(5) | A founder of a medical institution who has filed a report pursuant to paragraph (1) shall, if there is any modification of his or her business operation plan for overseas expansion of medical services or of an agreement for overseas expansion of medical services, notify the Minister of Health and Welfare of such modification without delay. <Amended on Jul. 9, 2019; Dec. 20, 2022> |
(6) | Except as provided in paragraphs (1) through (5), detailed matters necessary for the procedure and method of reporting, modification of reported details, verification of report, etc. shall be prescribed by Ministerial Decree of Health and Welfare. <Amended on Jul. 9, 2019; Dec. 20, 2022> |
Article 4 (Specialized Medical Departments Subject to Mandatory Assignment of Medical Specialist) |
"Specialized medical department prescribed by Presidential Decree" under the proviso of Article 6 (1) 1 of the Act shall mean the specialized department prescribed in Article 3 of the Regulation on Training and Qualification Test of Medical Specialist.
Article 5 (Evaluation of Attraction Institutions for Accreditation) |
(1) | Evaluation standards for medical institutions registered for attracting international patients pursuant to Article 6 (1) of the Act (hereinafter referred to as "medical institution attracting international patients") and persons registered for attracting international patients pursuant to Article 6 (2) (hereinafter referred to as "business entity attracting international patients") for accreditation, pursuant to Article 14 (1) of the Act, shall be according to the following classification: <Amended on Dec. 20, 2022> |
1. | Medical institutions attracting international patients: The following matters: |
(a) | Performance of attracting international patients; |
(b) | Performance of public relations and activities for attraction of international patients; |
(c) | The number of professional personnel to attract international patients; |
(d) | Type of medical departments and the number of medical specialists; |
(e) | Level of contribution to domestic medical services; |
(f) | Other matters prescribed by the Minister of Health and Welfare as necessary for evaluation of performance including attraction and medical treatment of international patients and the status of relevant disputes. |
2. | Medical institutions attracting international patients: The following matters: |
(a) | Matters under subparagraph 1 (a) through (c); |
(b) | Other matters prescribed by the Minister of Health and Welfare as necessary for evaluation of performance including attraction and medical treatment of international patients and the status of relevant disputes. |
(2) | If a medical institution attracting international patients and a business entity attracting international patients (hereinafter referred to as "attraction institution") intend to receive an evaluation and accreditation as an attraction institution pursuant to Article 14 (1) of the Act, they shall submit an application in the form prescribed by Ministerial Decree of Health and Welfare to the Minister of Health and Welfare. <Amended on Dec. 20, 2022> |
(3) | Where the Minister of Health and Welfare evaluates an attraction institution pursuant to paragraphs (1) and (2), he or she may order payment of any actual expenses for performing the evaluation as a fee. |
(4) | Where the Minister of Health and Welfare has completed an evaluation regarding the application for the evaluation and accreditation of the attraction institution filed under paragraph (2), he or she shall inform the applicant of the results of such evaluation and accreditation. <Amended on Dec. 20, 2022> |
(5) | Where it is necessary for the evaluation and accreditation under paragraph (4), the Minister of Health and Welfare may request the relevant institutions, corporations, or organizations and individuals, etc. to submit necessary data or to state their opinions. <Amended on Dec. 20, 2022> |
(6) | Where the Minister of Health and Welfare has accredited an attraction institution in accordance with the evaluation results under paragraph (4), he or she shall post the fact of accreditation on the website of the Ministry of Health and Welfare. <Amended on Dec. 20, 2022> |
(7) | Except as provided in paragraphs (1) through (6), matters necessary for detailed evaluation standards, methods of evaluation, evaluation procedures, notification of evaluation results, handling fee, etc. shall be determined and publicly notified by the Minister of Health and Welfare. |
[Title Amended on Dec. 20, 2022]
Article 6 (Use of Mark of Accredited Attraction Institutions and Re-Accreditation) |
(1) | An attraction institution that received an accreditation or conditional accreditation under Article 14 (1) of the Act or re-accreditation under the main clause of paragraph (4) of that Article (hereinafter referred to as "accreditation, etc.") may use the mark of the accredited attraction institution under Appendix 1, as determined and publicly notified by the Minister of Health and Welfare. <Amended on Dec. 20, 2022> |
(2) | An accredited attraction institution that intends to receive re-accreditation under the main clause of Article 14 (4) of the Act shall file an application for re-accreditation with the Minister of Health and Welfare, no later than two months prior to the expiration of the term of validity of accreditation, etc. <Amended on Dec. 20, 2022> |
(3) | Article 5 shall apply mutatis mutandis to the standards and procedures for re-accreditation under paragraph (2). In such cases, "accreditation" shall be deemed "re-accreditation." <Amended on Dec. 20, 2022> |
(4) | "Matters prescribed by Presidential Decree" in Article 14 (6) 4 of the Act means matters relating to the preferential allocation of international medical trainees or international patients who enter the Republic of Korea in accordance with an intergovernmental treaty. <Amended on Dec. 20, 2022> |
[Title Amended on Dec. 20, 2022]
Article 7 (Support for Medical Institutions Expanding Medical Services Overseas) |
(1) | With respect to the medical institutions having reported their overseas expansion of medical services pursuant to Article 4 of the Act (hereinafter referred to as "medical institutions expanding medical services overseas"), financial support or tax incentives specified in the following subparagraphs may be provided pursuant to Article 17 (1) of the Act: <Amended on Apr. 2, 2019; Dec. 20, 2022> |
6. | Technology guarantee under Article 28 (1) 2 of the Kora Technology Finance Corporation Act and credit guarantee under subparagraph 3 of that paragraph; |
7. | Tax credit in accordance with the provisions of tax-related statutes. |
(2) | Where a medical institution expanding medical services overseas intends to receive the support prescribed in paragraph (1), any of the following requirements shall be satisfied: |
1. | Details and region, etc. of overseas expansion of medical services corresponds to the policies of the Government; |
2. | Funding is deemed necessary based on the type, scale, etc. of overseas expansion of medical services; |
3. | Funding is deemed necessary for the overseas expansion of medical services, taking into account of financial status and organizational size, etc. of a medical institution; |
4. | Other cases where funding is deemed necessary, in light of a relevant medical institution’s characteristics or history of overseas expansion of medical services, or its performance, etc. of medical services. |
(3) | Where it is necessary to receive the support under paragraph (1), a medical institution expanding medical services overseas may request the Minister of Health and Welfare to confirm if the medical institution satisfies the requirements for support under paragraph (2). |
(4) | Where a medical institution expanding medical services overseas has received the support under paragraph (1), it shall inform the Minister of Health and Welfare of the support. |
(5) | Except as provided in paragraphs (2) through (4), detailed matters necessary for prescribing the requirements and confirmation, etc. of the aforementioned support shall be determined and publicly notified by the Minister of Health and Welfare. |
Article 8 (Formulation of Comprehensive Plan to Support Overseas Expansion of Medical Services and Attraction of International Patients) |
(1) | Where the Minister of Health and Welfare has established the comprehensive plan to support overseas expansion of medical services and attraction of international patients pursuant to Article 18 (1) of the Act, he or she shall publish notice of the details of the comprehensive plan in the Official Gazette, and inform the heads of the competent central administrative agencies and local governments of the details thereof. |
(2) | Where the Minister of Health and Welfare establishes an annual implementation plan pursuant to Article 18 (3) of the Act (hereafter in this paragraph referred to as "implementation plan"), he or she shall undergo deliberation by the policy deliberation committee under Article 19 (1) of the Act. In such cases, paragraph (1) shall apply mutatis mutandis to the procedures for formulating an implementation plan. <Amended on Jul. 2, 2024> |
[This Article Wholly Amended on Dec. 20, 2022]
Article 9 Deleted. <Jul. 2, 2024> |
Article 10 (Annual Report) |
Where it is necessary to prepare the report under Article 20 (1) of the Act, the Minister of Health and Welfare may request the head of concerned central administrative agencies, the head of local governments, the head of the public institutions under the Act on the Management of Public Institutions, a founder of the medical institution expanding medical services overseas and/or the attraction institution to submit information or opinions.
Article 11 (Designation of Supporting Institution) |
(1) | Standards for designation of the institutions or groups to be designated by the Minister of Health and Welfare pursuant to the provisions, with the exception of the subparagraphs, of Article 21 (1) of the Act (hereinafter referred to as "supporting institution") shall be as provided in the following subparagraphs: |
1. | A supporting institution must have at least one department and at least five professional personnel designated to exclusively and independently perform the affairs under each subparagraph of Article 21 (1) of the Act; |
2. | A supporting institution must have the facility and equipment necessary to perform the affairs under each subparagraph of Article 21 (1) of the Act; |
3. | A supporting institution must have an on-line work processing system that is necessary to perform the affairs under each subparagraph of Article 21 (1) of the Act; |
4. | A supporting institution must have finances necessary to perform the affairs under each subparagraph of Article 21 (1) of the Act. |
(2) | An institution or a group intending to be designated by the Minister of Health and Welfare pursuant to Article 21 (1) of the Act shall submit its application for designation as prescribed by Ordinance of Ministry of Health and Welfare (including an application electronically prepared) to the Minister of Health and Welfare, attached with the documents (including any documents electronically prepared) falling under following subparagraphs: |
1. | A document verifying satisfaction of the standards of designation pursuant to each subparagraph of paragraph (1); |
2. | Articles of incorporation or equivalent regulations for business operation of the institution or group; |
3. | A document showing business performance of the institution or group for the preceding three (3) years (where the period of business activity is less than three years, referring to the documents showing business performances during such period of business); |
4. | A document satisfying the execution of financial plan and settlement documents of the institution or group for the preceding two years (where the period of business activity is less than two years, referring to the documents satisfying the execution of financial plan and settlement status during such period of business). |
(3) | Where the Minister of Health and Welfare has received an application for designation pursuant to paragraph (2), the Minister shall determine whether to accept the application taking into account the matters under each of the following subparagraphs, and notify the results of the aforementioned determination to the applicant: |
1. | Whether or not the standards of designation under paragraph (1) is met; |
2. | Whether or not the applicant is able to perform the applied business and is in sound financial condition; |
3. | Whether or not the purposes of incorporation or business areas of the supporting institution are relevant to overseas expansion of medical services and attraction of international patients. |
(4) | Except as provided in paragraphs (1) through (3), detailed matters necessary for providing the standard and method of, application etc. for the aforementioned designation shall be determined and publicly notified by the Minister of Health and Welfare. |
Article 12 (Entrustment of Duties to Supporting Institution) |
(1) | Where the Minister of Health and Welfare entrusts its duties to the supporting institution pursuant to Article 21 (1) of the Act, the Minister shall give public notice of the trustee’s name and address, representative’s name, entrusted matters, etc. in the Official Gazette, and post the same information on the website of the Ministry of Health and Welfare. |
(2) | A supporting institution entrusted with duties pursuant to paragraph (1) shall submit a written business operation plan and financial execution plan for the entrusted duties to the Minister of Health and Welfare. |
(3) | "Duties prescribed by Presidential Decree" in Article 21 (1) 6 of the Act means the acceptance of notification of business performance under Article 11 (2) of the Act. <Amended on Apr. 28, 2020; Sep. 8, 2020> |
(4) | Where the Minister of Health and Welfare entrusts its duties to the supporting institution pursuant to Article 21 (1) of the Act, the Minister may support the supporting institution by bearing all or part of the expenses falling under the following subparagraphs: |
1. | Personnel expenses, rent and other operating expenses in the performance of entrusted duties; |
2. | Expenses for establishing/maintaining the facilities/equipment/programs, etc. to be incurred in the performance of entrusted duties; |
3. | Other expenses deemed by the Minister of Health and Welfare as particularly necessary to efficiently perform entrusted duties. |
Article 12-2 (Re-Entrustment of Duties of Supporting Institutions) |
(1) | Pursuant to Article 21 (2) of the Act, a supporting institution may re-entrust the following duties regarding the medical institutions attracting international patients to the Korea Institute for Healthcare Accreditation under Article 58-11 of the Medical Service Act: |
1. | Examination of whether the medical institutions attracting international patients comply with the evaluation standards prescribed in the items of Article 5 (1) 1; |
2. | Acceptance of an application filed under Article 5 (2). |
(2) | A supporting institution that intends to re-entrust some of its duties pursuant to Article 21 (2) of the Act shall formulate a plan regarding re-entrusted duties, including the following matters, and obtain approval thereof from the Minister of Health and Welfare: |
1. | Scope and period of re-entrusted duties; |
2. | Matters relating to termination of the contract for re-entrustment of duties; |
3. | Matters relating to bearing of expenses incurred in conducting the duties specified in the subparagraphs of paragraph (1); |
4. | Other matters deemed necessary by the Minister of Health and Welfare for evaluating the medical institutions attracting international patients. |
[This Article Added on Apr. 28, 2020]
Article 13 (Procedures for Revocation of Accreditation) |
Where the Minister of Health and Welfare revokes accreditation, etc. of the accredited attraction institutions or designation of a supporting institution pursuant to Article 25 (1) or (2) of the Act, the Minister shall post such facts on the website of the Ministry of Health and Welfare. <Amended on Dec. 20, 2022> [Title Amended on Dec. 20, 2022]
Article 14 (Criteria for Calculation of Penalty Surcharges) |
(1) | "Sales prescribed by Presidential Decree" in the main clause of Article 26 of the Act means the amounts classified in the following subparagraphs: <Amended on Apr. 28, 2020> |
1. | A person who has attracted international patients without formally registering as a designated attraction institution pursuant to Article 6 (1) and (2) of the Act: Total amount of sales from attracting international patients during the period of the violation; |
2. | A person who, in violation of Article 9 (1) of the Act, has received fees in excess of the fee rate publicly notified by the Minister of Health and Welfare under Article 9 (2) of the Act: Amount obtained by subtracting the commission calculated according to the commission rate publicly notified by the Minister of Health and Welfare pursuant to Article 9 (2) of the Act from the amount of commission actually paid for attracting international patients. |
(2) | "Cases prescribed by Presidential Decree" in the proviso of Article 26 of the Act means any of the following cases: <Amended on Sep. 8, 2020> |
1. | Where there is no business performance due to business suspension or other events; |
2. | Where the period of violation, etc. cannot be ascertained; |
3. | Where it is impracticable to objectively calculate the amount of sales because the data used to calculate such amount no longer exist or are destroyed due to natural disaster, etc. |
(3) | Detailed matters necessary for the method, etc. of calculating sales revenue as prescribed in paragraphs (1) shall be determined and publicly notified by the Minister of Health and Welfare. |
Article 14-2 (Imposition and Payment of Penalty Surcharges) |
(1) | When the Special Metropolitan City Mayor, a Metropolitan City Mayor, a Special Self-Governing City Mayor, a Do Governor, or a Special Self-Governing Province Governor (hereinafter referred to as "relevant Mayor/Do Governor") intends to impose a penalty surcharge pursuant to Article 26 of the Act, he or she shall give a written notice of the payment of a penalty surcharge, specifying the act of violation subject to the penalty surcharge, amount thereof, payment deadline, collecting agency, etc. |
(2) | A person in receipt of a notice under paragraph (1) shall pay the penalty surcharge to the receiving agency by the deadline stated in the payment notice of the penalty surcharge. <Amended on Dec. 12, 2023> |
(3) | Upon receipt of a penalty surcharge, a collecting agency referred to in paragraph (2) shall issue the receipt to the relevant payer, and notify the competent Mayor/Do Governor of the fact of payment without delay. |
[This Article Added on Sep. 8, 2020]
Article 15 (Monetary Awards to Reporters) |
(1) | Upon receipt of a report or a criminal accusation regarding a person falling under any subparagraph of Article 27 (1) of the Act, a competent administrative agency or investigative authority shall notify the relevant Mayor/Do Governor of such fact without delay. <Amended on Sep. 8, 2020> |
(2) | Where the relevant Mayor/Do Governor is notified pursuant to paragraph (1), he or she shall ascertain the details of notification and determine whether to pay a monetary award: Provided, That if a reporter or accuser falls under any of the following subparagraphs, the relevant Mayor/Do Governor shall not pay the award: <Amended on Sep. 8, 2020> |
1. | Where the same report or criminal accusation is subsequently made against the same violation that has already been reported or accused in accordance with Article 27 (1) of the Act was made; |
2. | Where a report or accusation is filed with respect to a matter for which judicial proceedings are pending; |
3. | Where a report or accusation is made in violation of the relevant statutes or regulations. |
(3) | Where the Mayor/Do Governor has determined to pay the monetary award to the reporter or accuser pursuant to paragraph (2), the Mayor/Do Governor shall inform the reporter or accuser of such determination. <Amended on Sep. 8, 2020> |
(4) | A reporter or accuser who is notified of a determination to pay a monetary award under paragraph (3) shall file an application for the payment of a monetary award with the relevant Mayor/Do Governor, as determined and publicly notified by the Minister of Health and Welfare. <Amended on Sep. 8, 2020> |
(5) | The relevant Mayor/Do Governor shall pay a monetary award to the reporter or accuser within 30 days from the date of receiving an application for the payment of a monetary award under paragraph (4). <Amended on Sep. 8, 2020> |
(6) | The amount of the monetary award under paragraph (5) shall be the amount to be determined and publicly notified by the Minister of Health and Welfare, within the scope of amount under each of the following subparagraphs: |
1. | Where having reported or accused an attraction institution which has attracted a person who is not an international patient: 10 million won; |
2. | Where having reported or accused a person who has attracted an international patient without registering for attracting international patients pursuant to Article 6 (1) and (2) of the Act: 10 million won; |
3. | Where having reported or accused a person who has violated Article 7, 9 or 15 of the Act: Three million won. |
(7) | Detailed matters necessary for the report or allegation, standards for payment of a monetary award, methods and procedures of payment, etc. as prescribed in paragraphs (1) through (6) shall be determined and publicly notified by the Minister of Health and Welfare. |
Article 16 (Criteria for Imposition of Administrative Fine) |
The criteria for the imposition of administrative fine pursuant to Article 31 of the Act shall be as prescribed in Appendix 2.
ADDENDA <Presidential Decree No. 27241, Jun. 21, 2016>
Article 1 (Enforcement Decree)
This Decree shall enter into force on June 23, 2016.
Article 2 (Applicability to Standards for Calculation of Penalty Surcharge)
In cases of calculating the period of violation as prescribed in Article 14 (1) 1, the calculation shall be made beginning from the time of a violation committed after enforcement of this Decree.
ADDENDA <Presidential Decree No. 29677, Apr. 2, 2019>
Article 1 (Enforcement Decree)
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 29962, Jul. 9, 2019>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 30642, Apr. 28, 2020>
Article 1 (Enforcement Decree)
This Decree shall enter into force on June 4, 2020.
Article 2 (Transitional Measures concerning Institutions Subject to Re-Entrustment of Duties of Supporting Institutions)
"The Korea Institute for Healthcare Accreditation under Article 58-11 of the Medical Service Act" in the amended provisions, with the exception of the subparagraphs, of Article 12-2 (1), shall be construed as "institution dedicated to accreditation under Article 58 (2) of the Medical Service Act" until September 4, 2020.
ADDENDUM<Presidential Decree No. 30993, Sep. 8, 2020>
This Decree shall enter into force on January 1, 2021.
ADDENDA <Presidential Decree No. 33098, Dec. 20, 2022>
Article 1 (Enforcement Decree)
This Decree shall enter into force on December 22, 2022.
Article 2 (Applicability to Documents to Be Submitted When Reporting Overseas Expansion of Medical Services)
The amended provisions of Article 3 (1) and (2) shall begin to apply where written reports on overseas expansion of medical services are filed on or after the date this Decree enters into force.
ADDENDUM <Presidential Decree No. 33913, Dec. 12, 2023>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 34645, Jul. 2, 2024>
Article 1 (Enforcement Decree)
This Decree shall enter into force on Jul. 10, 2024.
Article 2 (Transitional Measures concerning Indication of Institutions for Attraction of Certified Institutions)
Notwithstanding the amended provisions of subparagraphs 1 and 2 of Appendix 1, an attraction institution that has obtained certification, etc. before this Decree enters into force may use the mark of certification attraction institution under subparagraphs 1 and 2 of the previous Appendix 1 for one year from the date this Decree enters into force.