ENFORCEMENT DECREE OF THE MEDICAL DEVICES ACT
Presidential Decree No. 26375, Jun. 30, 2015
Amended by Presidential Decree No. 26844, Dec. 31, 2015
Presidential Decree No. 27209, May 31, 2016
Presidential Decree No. 28224, Aug. 1, 2017
Presidential Decree No. 29158, Sep. 11, 2018
Presidential Decree No. 29786, May 21, 2019
Presidential Decree No. 30156, Oct. 22, 2019
Presidential Decree No. 30511, Mar. 3, 2020
Presidential Decree No. 30545, Mar. 24, 2020
Presidential Decree No. 30993, Sep. 8, 2020
Presidential Decree No. 31013, Sep. 11, 2020
Presidential Decree No. 31380, Jan. 5, 2021
Presidential Decree No. 31783, Jun. 15, 2021
Presidential Decree No. 31974, Sep. 7, 2021
Presidential Decree No. 32014, Sep. 24, 2021
Presidential Decree No. 32348, Jan. 18, 2022
Presidential Decree No. 35250, Feb. 7, 2025
Presidential Decree No. 35669, Jul. 22, 2025
The purpose of this Decree is to prescribe matters mandated by the Medical Devices Act and matters necessary for the enforcement thereof.
| Article 2 (Events for Medical Device Day) |
| (2) | Where the State or a local government holds an event for Medical Device Day under Article 2-2 (2) of the Act, it may confer awards upon individuals or organizations that have made significant contributions to improving the safety of medical devices and promoting the sound development of the medical device-related industry. |
[This Article Added on Jul. 22, 2025]
| Article 3 Deleted. <Oct. 22, 2019> |
| Article 3-2 (Disqualification of, challenge to, and refrainment by, committee members) |
| (1) | If a member of the Medical Devices Committee (hereinafter referred to as the "Committee") under Article 5 (1) of the Act falls under any of the following subparagraphs, he or she shall be disqualified from participating in investigating and deliberating on the relevant agenda item: <Amended on Oct. 22, 2019; Mar. 3, 2020; Jul. 22, 2025> |
| 1. | Where the member or his or her spouse or ex-spouse is a party (if the party is a corporation or organization, including any of the executive officers and employees thereof; hereafter in this subparagraph and subparagraph 2, the same shall apply) to the relevant agenda item or is related to such party as a co-obligee or co-obligor; |
| 2. | Where a member is or was in a relative of a party to the relevant agenda item; |
| 3. | Where the member has offered expert testimony, statement, advice, research, services, or appraisal for the relevant agenda item; |
| 4. | Where a member or the legal entity, organization, etc. to which the member belongs is or was an agent for a party to the relevant agenda item; |
| 5. | Where the member has served in the corporation or organization that is a party to the relevant agenda item as an executive officer or employee thereof during the latest three years; |
| 6. | Where the chairperson deems that a member has any substantial grounds that undermine a fair examination and deliberation of the Committee, including direct interest in the relevant agenda item. |
| (2) | If a party finds it difficult to expect a fair investigation and deliberation from a member, he or she may file an application with the Committee for challenging the member, and the Committee shall decide on the application by resolution. In such cases, the member against whom the application for challenge is filed may not participate in the resolution. |
| (3) | If any of the grounds prescribed in the subparagraphs of paragraph (1) arises with respect to a member, or it is impracticable for a member to expect the fairness of investigation and deliberation, that member shall voluntarily refrain from investigating and deliberating on the relevant agenda item. |
[This Article Added on Sep. 11, 2018]
[(previous) Article 3-2 moved to Article 3-3 <Sep. 11, 2018>]
| Article 3-3 (Dismissal of members) |
The Minister of Food and Drug Safety may dismiss a member commissioned pursuant to Article 5 (4) of the Act, if: <Amended on Sep. 11, 2018; Oct. 22, 2019> | 1. | The member becomes incapable of performing his or her duties due to any mental and physical disorder; |
| 2. | Where a member is found to have committed any wrongdoing in connection with his or her duties; |
| 3. | The member is deemed unfit as a member, due to neglect of a duty, loss of dignity or other grounds; |
| 4. | Where a member voluntarily manifests his or her unfitness to perform his or her duties; |
| 5. | The member fails to refrain, despite falling under any of the grounds prescribed in the subparagraphs of Article 3-2 (1), in compliance with paragraph (3) of the same Article. |
[This Article Added on Dec. 31, 2015]
[Moved from Article 3-2 <Sep. 11, 2018>]
| Article 4 (Duties of chairpersons) |
| (1) | The chairpersons shall jointly represent the Committee and exercise overall control of the affairs of the Committee. <Amended on Jan. 5, 2021; Jan. 18, 2022> |
| (2) | When either of the chairpersons is unable to perform his or her duties due to any unavoidable reason, a vice chairperson designated in consultation between the chairpersons shall act on behalf of the chairperson. <Amended on Jan. 18, 2022> |
| (1) | The chairpersons shall jointly convene a meeting of the Committee and take turns to preside over the meeting. <Amended on Jan. 18, 2022> |
| (2) | The chairpersons shall convene a meeting without delay when requested by the Minister of Health and Welfare, the Minister of Food and Drug Safety, or a majority of all the incumbent members. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
| (3) | Resolutions at a meeting of the Committee shall require the attendance of a majority of all the incumbent members and the consent of a majority of those present. |
| Article 6 Deleted. <Jan. 18, 2022> |
| Article 7 (Subcommittees) |
| (1) | Deleted. <Oct. 22, 2019> |
| (2) | The chairperson of a subcommittee under Article 5 (6) of the Act (hereinafter referred to as "subcommittee") shall be elected by and from among the members of the subcommittee. <Amended on Oct. 22, 2019> |
| (3) | Members of a subcommittee shall be nominated by the chairperson of the Committee from among members who have abundant expertise and experience in the relevant field. |
| (4) | A subcommittee meeting shall be held with the attendance of a majority of all the incumbent subcommittee members and pass a resolution with the consent of 2/3 of those present. |
| (5) | Matters deliberated and resolved upon by a subcommittee shall be deemed deliberated and resolved upon by the Committee, except where the Chairperson deems that they need to be re-deliberated on by another subcommittee. |
| (6) | For the efficient deliberation of a subcommittee, a subcommittee may establish a subordinate committee that consists of not more than 10 members. <Added on Jun. 30, 2010; Oct. 22, 2019> |
| (7) | The provisions of paragraphs (2) through (4) shall apply mutatis mutandis to the composition and operation of subordinate committees referred to in paragraph (6). In such cases, "subcommittee" shall be construed as "subordinate committee," "head of the subcommittee" as "head of the subordinate committee" and "members of the subcommittee," as "members of the subordinate committee," respectively. <Added on May 31, 2016; Oct. 22, 2019> |
| (8) | Matters deliberated and resolved upon by a subordinate committee shall be deemed deliberated and resolved upon by the Committee, except where the Chairperson deems that they need to be re-deliberated on by the subcommittee or other subordinate committee. <Added on May 31, 2016> |
| (9) | Matters necessary for the types and operation of the subcommittees and subordinate committees and other relevant matters shall be prescribed by the Minister of Food and Drug Safety in consultation with the Minister of Health and Welfare, subject to resolution by the Committee. <Amended on Feb. 29, 2008; Mar. 15, 2010; Jun. 30, 2010; Mar. 23, 2013; May 31, 2016> |
[Title Amended on May 31, 2016]
| Article 8 (Research members) |
| (1) | In order to conduct in advance, the research and review of matters to be deliberated upon by the Committee, the Committee may have up to 10 research members. |
| (2) | Research members shall conduct in advance surveys and research on the matters to be deliberated upon by the Committee upon the order of the chairperson. |
| (3) | A research member may attend and speak at a Committee meeting. |
| (4) | In order to assist research members, the Committee may have up to 10 researchers. |
| (5) | Research members and researchers shall be appointed by the Minister of Food and Drug Safety from among persons who have adequate expertise and experience in medical devices. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
| Article 9 (Executive secretary and clerks) |
| (1) | The Committee shall have one executive secretary and a few clerks. |
| (2) | The executive secretary and clerks shall be appointed by the Minister of Food and Drug Safety from among public officials belonging to the Ministry of Food and Drug Safety. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013> |
| Article 10 (Allowances and travel expense) |
The Minister of Food and Drug Safety may pay allowances and travel expenses to members, travel expenses to professionals who have attended a committee meeting, and research expenses and travel expenses for surveys, research, etc. to research fellows and researchers, respectively, within the budget. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013; Jul. 19, 2022>
| Article 10-2 (Matters to be observed by distributors and lessors) |
A person who has filed a report on the distribution business of medical devices (hereinafter referred to as "distributor") or a person who has filed a report on the leasing business (hereinafter referred to as "lessor") pursuant to Article 17 (1) of the Act shall comply with the following pursuant to Article 18 (1) of the Act: <Amended on Jul. 19, 2022> | 1. | Matters concerning the method of ensuring the quality of medical devices and the maintenance of order in distribution related to safety, and so on, which are prescribed by Prime Ministerial Decree; |
| 2. | Except as provided in subparagraph 1, matters concerning the maintenance of order in distribution, and so on, which are prescribed by Decree of the Ministry of Health and Welfare. |
[This Article Added on Mar. 23, 2013]
| Article 10-3 (Media subject to voluntary deliberation of advertisements) |
| (1) | "Internet media prescribed by Presidential Decree" in Article 25 (1) 5 of the Act means the following media: |
| 3. | Internet media that mainly provides broadcast programs of a broadcasting business entity prescribed in subparagraph 3 of Article 2 of the Broadcasting Act online under a title, such as ‘broadcasting', ‘TV', ‘radio', or any other similar title; |
| (2) | "Advertising media prescribed by Presidential Decree" in Article 25 (1) 6 of the Act means any advertising medium providing social network services that has at least 100,000 daily users on average for the last three months as at the end of the preceding year. |
| (3) | "Where he or she intends to modify insignificant matters prescribed by Presidential Decree" in the proviso of Article 25 (2) of the Act means any of the following: |
| 1. | Where he or she intends to modify or delete words of the advertisement deliberated within the extent that the contents of such advertisement are not changed, or change the layout of such advertisement, such as a phrase or design; |
| 2. | Where he or she has obtained permission or certification for change or intends to change the contents of the advertisement deliberated as stated in the notification on change pursuant to Article 12 of the Act. |
| (4) | "Advertisement with the contents prescribed by Presidential Decree, such as an advertisement for a group of experts including medical personnel" in Article 25 (3) 4 of the Act means an advertisement for the purpose of providing professional contents to any of the following persons: |
| 3. | Medical service technologists, information managers for public health and medical services, and opticians prescribed in Article 1-2 of the Medical Service Technologists Act. |
[This Article Added on Jun. 15, 2021]
[(previous) Article 10-3 moved to Article 10-6 <Jun. 15, 2021>]
| Article 10-4 (Voluntary deliberation, procedures for re-deliberation of advertisements) |
| (1) | Deliberations under Article 25 (1) of the Act shall be conducted in accordance with the standards for deliberation prepared by an institution or organization reported to the Minister of Food and Drug Safety pursuant to Article 25-2 (1) of the Act (hereinafter referred to as "voluntary deliberation agency") pursuant to paragraph (2) of the same Article and the methods and procedures for deliberation prescribed pursuant to paragraph (5) of the same Article. |
| (2) | A person who intends file an application for re-deliberation pursuant to Article 25 (4) of the Act shall file an application for re-deliberation with a voluntary deliberation agency which has deliberated on the relevant advertisement, stating the purport of and grounds for the application for re-deliberation. |
| (3) | An voluntary deliberation agency shall notify a person who files an application for re-deliberation of the results of such re-deliberation within 10 days from the date on which the agency receives the application for re-deliberation pursuant to paragraph (2); provided, where the agency is unable to process the application within the period due to an unavoidable cause, the agency shall notify the person who files an application for re-deliberation of the cause of postponing a determination and expected deadline for processing. |
| (4) | A person who intends to file an objection to the results of the re-deliberation by a voluntary deliberation agency pursuant to Article 25 (5) of the Act shall submit a written objection prescribed by Prime Ministerial Decree and the relevant documents to the Minister of Food and Drug Safety. |
| (5) | The Minister of Food and Drug Safety shall notify a person who raises an objection of the results of deliberation within 30 days from the date on which the Minister receives the objection under paragraph (4); provided, where the Minister is unable to process it within the period due to an unavoidable cause, the Minister shall notify the person who raises an objection of the cause of postponing a determination and expected deadline for processing. |
| (6) | The Minister of Food and Drug Safety shall notify the result of deliberation on objections filed under the main clause of paragraph (5) to the voluntary deliberation agency which has deliberated on the relevant advertisement. |
[This Article Added on Jun. 15, 2021]
| Article 10-5 (Organization of voluntary deliberation agency) |
| (1) | "Institution or organization that meets the criteria prescribed by Presidential Decree" in Article 25-2 (1) 1 of the Act means an institution or organization related to medical devices, the partners, partnership members, or other members of which are comprised of the following persons: <Amended on Jul. 19, 2022> |
| 1. | A person who has obtained manufacturing business permission under Article 6 (1) of the Act (hereinafter referred to as "manufacturer"); |
| 2. | A person who has obtained import business permission under Article 15 (1) of the Act (hereinafter referred to as "importer"); |
| 3. | A person who has filed a notification on repair business under Article 16 (1) of the Act; |
| (2) | "Organization ... that satisfies the standards prescribed by Presidential Decree" in Article 25-2 (1) 2 of the Act means a consumer organization satisfying the following standards: |
| 2. | The details related to medical devices and advertisements shall be included in the purpose of establishing an organization and the scope of its affairs. |
| (3) | An institution or organization under subparagraphs of Article 25-2 (1) of the Act shall have all of the following to organize and operate a voluntary deliberation agency: |
| 1. | At least one department and three full-time workers (persons with abundant knowledge and experience in the field of medical devices or advertisement shall be included) that are exclusively responsible for affairs regarding deliberation on and monitoring of advertisements of medical devices under Article 25 and 25-4 of the Act; |
| 2. | Computerized equipment and an office to be used to perform affairs regarding deliberation on and monitoring of advertisements of medical devices under Articles 25 and 25-4 of the Act. |
| (4) | An institution or organization that intends to report the performance of affairs regarding deliberation on advertisements of medical devices pursuant to Article 25-2 (1) of the Act shall submit a written report and related documents prescribed by Prime Ministerial Decree to the Minister of Food and Drug Safety. |
| (5) | The Minister of Food and Drug Safety shall disclose the matters reported pursuant to paragraph (4) on the website of the Ministry of Food and Drug Safety. |
[This Article Added on Jun. 15, 2021]
| Article 10-6 (Designation of and entrustment of duties to integrated medical device information center) |
| (1) | The Minister of Food and Drug Safety shall designate the National Institute of Medical Device Safety Information prescribed in Article 42 of the Act as the integrated medical device information center pursuant to Article 31-4 (1) of the Act. <Amended on Sep. 11, 2018> |
| (2) | The Minister of Food and Drug Safety shall entrust the following duties to the National Institute of Medical Device Safety Information pursuant to Article 31-4 (1) of the Act: <Amended on Sep. 11, 2018> |
| 1. | Collection, investigation, processing, use and provision of information on distribution of medical devices prescribed in Article 31-2 of the Act and information on medical devices prescribed in Article 31-3 (2) of the Act (hereinafter referred to as "integrated medical device information"); |
| 2. | Operation of the integrated medical device information system prescribed in Article 31-3 (1) of the Act; |
| 3. | Management of Unique Device Identifiers on medical devices registered pursuant to Article 31-3 (2) of the Act; |
| 4. | Development and dissemination of programs necessary for submission and registration of integrated medical device information and Unique Device Identifiers on medical devices and other support; |
| 5. | Formulation and implementation of master plans for standardization of integrated medical device information recorded in and managed by the integrated medical device information system pursuant to Article 31-3 of the Act; |
| 6. | Study, education and publicity for standardization of integrated medical device information recorded in and managed by the integrated medical device information system pursuant to Article 31-3 of the Act; |
| 7. | Other duties deemed necessary for the management and technical support, etc. of the integrated medical device information system by the Minister of Food and Drug Safety. |
[This Article Added on Aug. 1, 2017]
[Moved from Article 10-3 <Jun. 15, 2021>]
| Article 11 (Criteria for calculation of penalty surcharges) |
| (1) | The amount of a penalty surcharge under Article 38 (2) of the Act shall be calculated by applying the criteria specified in Appendix 1, in accordance with the criteria for business suspension disposition prescribed by Prime Ministerial Decree taking into consideration the types, severity, etc. of violations. <Amended on Feb. 29, 2008; Mar. 15, 2010; Oct. 7, 2011; Mar. 23, 2013; Jan. 5, 2021> |
| (2) | The Minister of Food and Drug Safety, a Special Self-Governing City Mayor, a Special Self-Governing Province Governor, or the head of a Si/Gun/Gu (Gu refers to an autonomous Gu; hereinafter the same shall apply) may increase or decrease the amount of a penalty surcharge by up to 1/2 of the amount thereof calculated under paragraph (1), taking into account the business scale of the medical device handler, severity and frequency of violation, and other relevant matters; provided, even in cases of increase, the total amount of the penalty surcharge shall not exceed one billion won. <Amended on Oct. 7, 2011; Mar. 23, 2013; May 21, 2019> |
| Article 11-2 (Criteria for imposition of penalty surcharges for manufacture of harmful medical devices) |
| (1) | The amount of penalty surcharges imposed pursuant to Article 38-2 (1) of the Act shall be twice the amount calculated by multiplying the sales volume by the sales price of an item in violation. |
| (2) | In calculating the amount of penalty surcharges under paragraph (1), the sales volume shall be calculated by deducting the actual volume unsold for reasons, such as recovery, return, and inspection, from the volume of shipment during the sales period, and if the sales price is changed during the sales period, the amount of penalty surcharges shall be the sum of the amounts calculated respectively for each sales period during which the sales prices change. |
| (3) | The Minister of Food and Drug Safety may reduce the amount of penalty surcharges within the scope of 1/2 of the penalty surcharges calculated pursuant to paragraph (1), in consideration of matters referred to in the subparagraphs of Article 38-2 (2) of the Act. |
[This Article Added on Jan. 18, 2022]
| Article 12 (Procedures for imposition and payment of penalty surcharges) |
| (1) | When the Minister of Food and Drug Safety, a Special Self-Governing City Mayor, a Special Self-Governing Province Governor, or the head of a Si/Gun/Gu intends to impose a penalty surcharge under Article 38 and 38-2 of the Act, he or she shall give a written notification to pay the penalty surcharge, specifying the type of violation, the amount of the relevant penalty surcharge, the methods and period of filing an objection, etc. <Amended on Oct. 7, 2011; Mar. 23, 2013; May 21, 2019; Jan. 18, 2022> |
| (2) | Any person in receipt of notification under paragraph (1) shall pay a penalty surcharge to a collecting agency designated by the Minister of Food and Drug Safety, the Special Self-Governing City Mayor, the Special Self-Governing Province Governor, or the head of a Si/Gun/Gu within 20 days from the date of receipt of such notification. <Amended on Mar. 23, 2013; May 21, 2019; Dec. 12, 2023> |
| (3) | Upon receiving a payment of a penalty surcharge under paragraph (2), the relevant collecting agency shall issue a receipt to the payer and notify the fact, without delay, of collection to the Minister of Food and Drug Safety, a Special Self-Governing City Mayor, a Special Self-Governing Province Governor, or the head of a Si/Gun/Gu without delay. <Amended on Mar. 23, 2013; May 21, 2019> |
| (4) | Deleted. <Sep. 24, 2021> |
| Article 12-2 (Disposition on defaulters of penalty surcharges) |
| (1) | If a person obligated to pay a penalty surcharge under the main clause of Article 38 (4) of the Act fails to pay it by the deadline for payment, the Minister of Food and Drug Safety, a Special Self-Governing City Mayor, a Special Self-Governing Province Governor, or the head of a Si/Gun/Gu shall issue a demand note within 15 days after the elapse of the deadline for payment. In such cases, the deadline for payment shall be specified to be within 10 days from the issuance date of demand note. <Amended on Oct. 7, 2011; Mar. 23, 2013; May 21, 2019> |
| (2) | If a person who has not paid a penalty surcharge under paragraph (1) fails to pay it by the deadline for payment even after receiving a demand note, the Minister of Food and Drug Safety, a Special Self-Governing City Mayor, a Special Self-Governing Province Governor, or the head of a Si/Gun/Gu shall revoke the imposition of the penalty surcharge and issue the disposition for suspension of business; provided, in cases falling under the proviso of Article 38 (4) of the Act, such penalty surcharge shall be collected in the same manner as delinquent national taxes are collected or in accordance with the Act on the Collection of Local Administrative Penalty Charges. <Amended on Jun. 30, 2015; May 21, 2019; Mar. 24, 2020> |
| (3) | Where the imposition of a penalty surcharge is to be revoked and business suspension is to be ordered under the main clause of paragraph (2), a person subject to such disposition shall be notified thereof in writing, with the matters required for the disposition for business suspension, such as the grounds for the changed disposition and the period of business suspension. <Amended on May 21, 2019> |
[This Article Added on Jul. 3, 2007]
| Article 12-3 (Announcement of violations) |
The announcement of violations under Article 38-3 of the Act shall be made in a manner of posting the following information on the website of the announcing agency: <Amended on Jan. 18, 2022> | 1. | A title stating "announcement of violation of the Medical Devices Act"; |
| 2. | The product name of the medical device; |
| 3. | The category name of the business subject to disposition; |
| 4. | The name of the enterprise (name of the entity) and its location; |
| 5. | The details of violation and the relevant statutory provisions; |
| 6. | The details, date, and duration of disposition. |
[This Article Added on May 21, 2019]
[(previous) Article 12-3 moved to Article 12-4 <May 21, 2019>]
| Article 12-4 (Operation of National Institute of Medical Device Safety Information) |
Where necessary for financial support, etc. for the National Institute of Medical Device Safety Information under Article 42 of the Act, the Minister of Food and Drug Safety may request the head of the National Institute of Medical Device Safety Information to submit its business plan, budgetary documents for each business year, and other data. <Amended on Mar. 23, 2013; Sep. 11, 2018> [This Article Added on Oct. 7, 2011]
[Title Amended on Sep. 11, 2018]
[Moved from Article 12-3 <May 21, 2019>]
| Article 12-5 (Subjects and types of insurance or mutual aid) |
| (1) | "Manufacturers and importers of medical devices prescribed by Presidential Decree" in Article 43-6 (1) of the Act means manufacturers or importers of medical devices which are continuously maintained for at least 30 days after being inserted into the human body (hereinafter referred to as "implantable medical devices"); provided, the following manufacturers and importers of implantable medical devices shall be excluded: |
| 1. | A manufacturer of an implantable medical device who has obtained manufacturing permission or manufacturing certification under Article 6 (2) of the Act only for the purpose of export; |
| 2. | An importer of implantable medical devices who has obtained import permission or import certification under Article 15 (2) of the Act only for the purpose of export; |
| 3. | An importer of implantable medical devices who meets all of the following requirements: |
| a. | The insurance or mutual aid held by a foreign manufacturer or distributor of implantable medical devices shall meet the criteria for the insured amount under Article 12-6 (1); |
| b. | The insurance or mutual aid under item a shall cover even the damage incurred to domestic patients. |
| (2) | The types of insurance or mutual aid (hereinafter referred to as "medical device liability insurance, etc.") to be purchased by a manufacturer or importer of implantable medical devices under the main clause, with the exception of the subparagraphs, of paragraph (1) shall be as follows: |
| 1. | Liability insurance, which is liable to pay a patient who suffers damage caused by a medical device not less than the amount prescribed in Article 12-6 (1); |
| 2. | Other insurance or mutual aid including the details under subparagraph 1. |
[This Article Added on Jul. 19, 2022]
| Article 12-6 (Insured amount of medical device liability insurance) |
| (1) | The insured amount of medical device liability insurance, etc. shall not be less than the following amounts; provided, the insurance benefits paid shall not exceed the amount of actual damage, except in cases falling under the proviso of subparagraph 1: |
| 1. | In cases of death: 150 million won per person; provided, where the amount of actual damage caused by death is less than 20 million won, the compensations shall be 20 million won per person; |
| 2. | In cases of injury: 30 million won per person; |
| 3. | Where a person has completed treatment for an injury and can no longer expect further therapeutic improvement, resulting in persistent symptoms and a lasting physical disability as a result of the injury (hereinafter referred to as "sequelae"): 150 million won per person; |
| 4. | Where an injured person dies due to the injury while undergoing medical treatment: The aggregate of the amounts referred to in subparagraphs 1 and 2; |
| 5. | Where an injured person suffers from a sequelae caused by his or her injury during treatment: The aggregate of the amounts referred to in subparagraphs 2 and 3; |
| 6. | Where a person dies due to the injury after the amount referred to in subparagraph 3 has been paid: The amount referred to in subparagraphs 1 through 3, minus the amount of the insurance benefits paid for the period after the date of death. |
| (2) | A manufacturer or importer of medical devices required to purchase insurance or mutual aid under Article 43-6 (1) of the Act shall purchase medical device liability insurance, etc. no later than the day immediately before the date of the distribution of implantable medical devices. |
| (3) | A manufacturer or importer of implantable medical devices who has purchased medical device liability insurance policy, etc. (including an importer of implantable medical devices under Article 12-5 (1) 3; hereafter in this Article the same shall apply) shall enter the name of the insurer, etc., the insured, the insured amount, the effective period, etc. in the information system determined by the Minister of Food and Drug Safety by the following periods: |
| 1. | A manufacturer or importer of implantable medical devices under the main clause, with the exception of the subparagraphs, of Article 12-5 (1): Within 14 days from the date he or she purchases medical device liability insurance, etc.; |
| 2. | An importer of implantable medical devices under Article 12-5 (1) 3: Three days before the date of initial importation of implantable medical devices for which import permission or import certification has been granted pursuant to Article 15 (2) of the Act. |
| (4) | A manufacturer or importer of implantable medical devices who has purchased medical device liability insurance, etc. shall, if any information entered into the information system is changed or the medical device liability insurance, etc. is renewed pursuant to paragraph (3), enter the details into the information system within 3 days from the date of such change or renewal. |
| (5) | Notwithstanding paragraphs (3) and (4), an insurer, etc. of medical device liability insurance, etc. may enter information related to the purchase of medical device liability insurance, etc. on behalf of a manufacturer or importer of implantable medical devices in the information system. |
[This Article Added on Jul. 19, 2022]
| Article 13 (Delegation of authority) |
| (1) | The Minister of Food and Drug Safety shall delegate the following authority to the commissioner of each Regional Food and Drug Administration pursuant to Article 44 (1) of the Act: <Amended on Mar. 23, 2013; Jun. 30, 2015; May 31, 2016; Aug. 1, 2017; May 21, 2019; Jan. 18, 2022; Feb. 7, 2025> |
| 1. | Approval for manufacturing business under Article 6 (1) of the Act; |
| 2. | Deleted; <Jun. 30, 2015> |
| 3. | Conditional approval for manufacturing business under Article 7 of the Act; |
| 4. | Deleted; <Jun. 30, 2015> |
| 5. | Deleted; <Jun. 30, 2015> |
| 6. | Approval of amendment to approval for manufacturing business under Article 12 of the Act; |
| 7. | Acceptance of notification on permanent closure, temporary closure, resumption, and changes under Article 14 of the Act; |
| 8. | Approval for import business under Article 15 (1) of the Act; |
| 9. | Deleted; <Jun. 30, 2015> |
| 10. | Conditional approval for import business under Article 7 of the Act, which is applied mutatis mutandis under Article 15 (6) of the Act; |
| 11. | Deleted; <Jun. 30, 2015> |
| 12. | Approval of amendment to approval for import business under Article 12 of the Act, which is applied mutatis mutandis under Article 15 (6) of the Act; |
| 13. | Acceptance of notification on permanent closure, temporary closure, resumption, and changes under Article 14 of the Act, which is applied mutatis mutandis under Article 15 (6) of the Act; |
| 13-2. | Orders to report and announce a recall plan of a medical device causing harm under Article 31 (2) and (3) of the Act; |
| 13-3. | Full or partial exemption from administrative dispositions under Article 31 (6) of the Act; |
| 13-4. | Investigations into the cause of inclusion of foreign substances and other necessary measures under Article 31-5 (2) of the Act; |
| 13-5. | Publication of the fact of the discovery of foreign substances, the investigation results, and the plan of measures under Article 31-5 (3) of the Act; |
| 14. | Orders to report, and entry, inspection, inquiries, and collection under Article 32 of the Act; |
| 14-2. | Necessary measures, such as the suspension of import, and cancellation of such measures under Article 32-2 (2) and (3) of the Act; |
| 15. | Inspection orders under Article 33 of the Act; |
| 16. | Orders for suspension of sale, recall, destruction, or other measures and orders for public announcement under Article 34 (1) of the Act; |
| 17. | Orders to destroy, envelop, or seal goods at issue or take other necessary measures under Article 34 (2) of the Act; |
| 18. | Orders to suspend the use of, or repair, a medical device, or take other necessary measures under Article 35 of the Act; |
| 19. | Orders to revoke approval or certification, prohibit manufacturing or import of item categories or items, or suspend business activities under Article 36 of the Act; |
| 20. | Imposition and collection of penalty surcharges under Article 38 of the Act; |
| 21. | Hearings on the revocation of approval or certification, the prohibition of manufacturing or import of item categories or items, or the suspension of business activities under Article 39 of the Act; |
| 21-2. | Approval for commission, education, dismissal or exclusive access of medical device surveillance consumer officers pursuant to Article 40-2 of the Act; |
| 22. | Renewal of permits for manufacturing business or permits for import business under Article 49 of the Act; |
| 23. | Collection of fees for approval of manufacturing business or approval for import business and for approval of amendment thereto under Article 50 of the Act; |
| 24. | Imposition and collection of administrative fines prescribed in Article 56 (1) of the Act. |
| (2) | Deleted. <Sep. 8, 2020> |
[This Article Wholly Amended on Oct. 7, 2011]
| Article 13-2 Deleted. <Sep. 7, 2021> |
| Article 13-3 (Management of sensitive information and personally identifiable information) |
The Minister of Food and Drug Safety (including persons to whom the authority of the Minister of Food and Drug Safety is delegated or entrusted under Article 44 of the Act), a Special Self-Governing City Mayor, a Special Self-Governing Province Governor, or the head of a Si/Gun/Gu (including persons to whom his or her authority is delegated or entrusted where such authority is delegated or entrusted) may manage data containing information on health under Article 23 of the Personal Information Protection Act (hereinafter referred to as "health information"), information falling under criminal history records under subparagraph 2 of Article 18 of the Enforcement Decree of that Act (limited to information violating statues concerning medical devices) or resident registration numbers or foreigner registration numbers prescribed in Article 19 of that Decree, to perform the following business affairs; provided, health information shall be excluded in cases of business affairs provided in subparagraphs 4 and 8: <Amended on Mar. 23, 2013; Jun. 30, 2015; Aug. 1, 2017; May 21, 2019; Dec. 20, 2022; Feb. 7, 2025; Jul. 22, 2025> | 1. | Business affairs related to manufacturing business approvals, etc. under Article 6 of the Act; |
| 2. | Business affairs related to conditional manufacturing business approvals, etc. under Article 7 of the Act; |
| 3. | Business affairs related to approval of amendment to manufacturing business approvals, etc. under Article 12 of the Act; |
| 4. | Business affairs related to notification of manufacturers on temporary shutdown, permanent closure, resumption, and changes under Article 14 of the Act; |
| 5. | Business affairs related to import business approval, conditional business approval, approval of amendment to import business approvals, and notification on temporary shutdown, permanent closure, resumption, and changes under Article 15 of the Act; |
| 6. | Business affairs related to notification on repair business and changes thereto, and notification on permanent closure, temporary shutdown, resumption, and changes under Article 16 of the Act; |
| 7. | Business affairs related to notification on distribution business and leasing business, changes thereof, and notification on permanent closure, temporary shutdown, resumption, and changes under Article 17 of the Act; |
| 7-2. | Business affairs related to the notification, change, and closure, suspension or resumption of business by a medical device sales promoter under Article 18-2 of the Act; |
| 7-3. | Business affairs related to preparing, keeping or submitting data by handlers or users of medical devices subject to tracking management prescribed in Article 30 (1) of the Act; |
| 7-4. | Business affairs related to the collection, analysis, and evaluation of actual use information under Article 30 (3) of the Act; |
| 7-5. | Business affairs related to reports on patients who have used the relevant medical devices in relation to their side effects, recall of such medical devices, and notification thereof under Article 31 of the Act; |
| 8. | Business affairs related to the issuance of identification documents to relevant public officials for entry, inspection, questioning, and collection under Article 32 of the Act to verify their authority; |
| 9. | Business affairs related to administrative dispositions under Articles 34 through 37 of the Act; |
| 10. | Business affairs related to the imposition and collection of penalty surcharges under Article 38 of the Act; |
| 11. | Business affairs related to hearings under Article 39 of the Act; |
| 12. | Business affairs related to the appointment of medical device surveillance officers of medical devices under Article 40 of the Act; |
| 13. | Business affairs related to the succession to the status of a manufacturer, etc. or a medical device sales promoter under Article 47 of the Act; |
| 14. | Business affairs related to the renewal of an approval, certification, or notification acceptance letter under Article 49 of the Act. |
[This Article Added on Jan. 6, 2012]
[Moved from Article 13-2 <Sep. 11, 2018>]
| Article 14 (Criteria for imposition of administrative fines) |
The criteria for imposition of administrative fines under Article 56 (1) of the Act shall be as specified in Appendix 2. [This Article Added on Oct. 7, 2011]
ADDENDA <Presidential Decree No. 18401, Nov. 25, 2004>
Article 1 (Enforcement date)
This Decree shall enter into force on May 30, 2004.
ADDENDA <Presidential Decree No. 19513, Jun. 12, 2006>
Article 1 (Enforcement date)
This Decree shall enter into force on July 1, 2006.
ADDENDUM <Presidential Decree No. 20157, Jul. 3, 2007>
This Decree shall enter into force on July 4, 2007; provided, the amended provisions of Article 13 shall enter into force 30 days after the date of their promulgation.
ADDENDA <Presidential Decree No. 20679, Feb. 29, 2008>
Article 1 (Enforcement date)
This Decree shall enter into on the date of its promulgation.
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement date)
This Decree shall enter into force on March 19, 2010. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 22247, Jun. 30, 2010>
Article 1 (Enforcement date)
This Decree shall enter into force on January 1, 2011; provided, the amended provisions of Article 7 shall enter into force on the date of its promulgation. Article 2 (Transitional measures concerning dispositions)
Notifications on medical device repair business accepted, dispositions issued, and other acts conducted by administrative agencies under the previous provisions as at the time this Decree enters into force shall be deemed notifications on medical device repair business accepted, dispositions issued, and other acts conducted by administrative agencies under the corresponding provisions of this Decree, and notifications filed with, and other acts conducted in relation to, administrative agencies under the previous provisions shall be deemed notifications filed with, and other acts conducted in relation to, administrative agencies under the corresponding provisions of this Decree.
ADDENDA <Presidential Decree No. 23200, Oct. 7, 2011>
Article 1 (Enforcement date)
This Decree shall enter into force on October 8, 2011; provided, the amended provisions of Article 12-3 shall enter into force on April 8, 2012, and the part concerning the delegation of authority over item categories and items subject to manufacturing approval or import approval among the amended provisions of Article 13 shall enter into force six months after the date of its promulgation. Article 2 (Transitional measures concerning dispositions)
Approvals granted, notifications accepted, dispositions issued, and other acts conducted by administrative agencies pursuant to the previous provisions as at the time this Decree enters into force shall be deemed approvals granted, notifications accepted, dispositions issued, and other acts conducted by administrative agencies pursuant to the corresponding provisions of this Decree, and applications for approvals filed with, notifications filed with, and other acts conducted in relation to, administrative agencies pursuant to the previous provisions shall be deemed applications for approvals filed with, notifications filed with, and other acts conducted in relation to, administrative agencies under the corresponding provisions of this Decree.
Article 3 (Transitional measures concerning administrative fines)
| (1) | Notwithstanding the amended provisions of Appendix 2, the previous criteria for imposition of administrative fines shall apply to violations committed before this Decree enters into force. |
| (2) | An administrative fine imposed for a violation committed before this Decree enters into force shall not be included in the calculation of the frequency of violation under the amended provisions of Appendix 2. |
ADDENDA <Presidential Decree No. 23488, Jan. 6, 2012>
Article 1 (Enforcement date)
This Decree shall enter into on the date of its promulgation. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 24480, Mar. 23, 2013>
Article 1 (Enforcement date)
This Decree shall enter into on the date of its promulgation.
Article 2 (Enforcement date of partially amended medical devices act) "The date prescribed by the Presidential Decree" in Article 1 (2) of the Addenda to the wholly amended Government Organization Act (Act No. 11690) means the promulgation date of this Decree. Article 3 (Transitional measures concerning members of the Medical Devices Committee)
| (1) | Members of the Medical Devices Committee appointed or commissioned by the Minister of Health and Welfare pursuant to the previous provisions as at the time this Decree enters into force shall be deemed appointed or commissioned by the Minister of Food and Drug Safety pursuant to the amended provisions of Article 2 (3). |
| (2) | Research members and researchers of the Medical Devices Committee appointed by the Minister of Health and Welfare pursuant to the previous provisions as at the time this Decree enters into force shall be deemed appointed by the Minister of Food and Drug Safety pursuant to the amended provisions of Article 8 (5). |
ADDENDA <Presidential Decree No. 25357, May 21, 2014>
Article 1 (Enforcement date)
This Decree shall enter into force on August 7, 2014.
ADDENDA <Presidential Decree No. 26375, Jun. 30, 2015>
Article 1 (Enforcement date)
This Decree shall enter into force on July 29, 2015; provided, the amended provisions of Article 12-2 (2) and Appendix 2 shall enter into force on the date of their promulgation. Article 2 (Transitional measures concerning dispositions on defaulters of penalty surcharges)
The amended provisions of Article 12-2 (2) shall apply to any person who fails to pay his or her penalty surcharge by the deadline for payment even after receiving a demand note before this Decree enters into force. Article 3 (Transitional measures concerning delegation of authority)
Notwithstanding amended provisions of Article 13 (1), the previous provisions shall govern the cases where procedures for manufacturing approval, manufacturing notification, import approval, import notification, etc. of medical devices are in progress; procedures for reporting of a recall plan for a medical device, issuing an order for announcement of such plan to the public, and granting full or partial exemption from an administrative disposition are in progress; or procedures for collecting an administrative fine imposed on any person who fails to report the production results, etc., of medical devices are in progress.
ADDENDUM <Presidential Decree No. 26844, Dec. 31, 2015>
This Decree shall enter into on the date of its promulgation.
ADDENDUM <Presidential Decree No. 27209, May 31, 2016>
This Decree shall enter into on the date of its promulgation.
ADDENDUM <Presidential Decree No. 28224, Aug. 1, 2017>
ADDENDUM <Presidential Decree No. 29158, Sep. 11, 2018>
ADDENDUM <Presidential Decree No. 29786, May 21, 2019>
This Decree shall enter into force on June 12, 2019.
ADDENDUM <Presidential Decree No. 30156, Oct. 22, 2019>
This Decree shall enter into force on October 24, 2019.
ADDENDUM <Presidential Decree No. 30511, Mar. 3, 2020>
This Decree shall enter into on the date of its promulgation.
ADDENDA <Presidential Decree No. 30545, Mar. 24, 2020>
Article 1 (Enforcement date)
This Decree shall enter into on the date of its promulgation. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 30993, Sep. 8, 2020>
This Decree shall enter into force on January 1, 2021.
ADDENDA <Presidential Decree No. 31013, Sep. 11, 2020>
Article 1 (Enforcement date)
This Decree shall enter into force on September 12, 2020.
ADDENDUM <Presidential Decree No. 31380, Nov. 5, 2021>
This Decree shall enter into on the date of its promulgation. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 31783, Jun. 15, 2021>
This Decree shall enter into force on June 24, 2021.
ADDENDA <Presidential Decree No. 31974, Sep. 7, 2021>
Article 1 (Enforcement date)
This Decree shall enter into on the date of its promulgation.
ADDENDA <Presidential Decree No. 32014, Sep. 24, 2021>
Article 1 (Enforcement date)
This Decree shall enter into on the date of its promulgation. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 32348, Jan. 18, 2022>
This Decree shall enter into force on January 21, 2022; provided, the amended provisions of Appendix 2 shall enter into force on the date of the promulgation, and the amended provisions of Article 13 shall enter into force on February 18, 2022.
ADDENDA <Presidential Decree No. 32817, Jul. 19, 2022>
Article 1 (Enforcement date)
This Decree shall enter into force on July 21, 2022.
Article 2 (Applicability to subjects of medical device liability insurance, etc. and special cases concerning timing to purchase medical device liability insurance, etc.)
| (1) | The amended provisions of Articles 12-5 and 12-6 shall also apply to manufacturers and importers of implantable medical devices who have obtained manufacturing permission, manufacturing certification, import permission, or import certification (excluding persons who have obtained manufacturing permission, manufacturing certification, import permission, or import certification only for export) before this Decree enters into force. |
| (2) | Notwithstanding the amended provisions of Article 12-6 (2), a manufacturer or importer of implantable medical devices falling under paragraph (1) shall purchase medical device liability insurance, etc. within 6 months from the date this Decree enters into force. |
Article 3 (Special cases concerning entry into information system for medical device liability insurance, etc.)
If an importer of implantable medical devices who has obtained import permission or import certification before this Decree enters into force imports an implantable medical device that meets the standards under the amended provisions of the items of Article 12-5 (1) 3, he or she shall enter the relevant information in the information system within 1 month from the date this Decree enters into force, notwithstanding the amended provisions of Article 12-6 (3) 2.
ADDENDUM <Presidential Decree No. 33112, Dec. 20, 2022>
This Decree shall enter into on the date of its promulgation.
ADDENDUM <Presidential Decree No. 33913, Dec. 12, 2023>
This Decree shall enter into on the date of its promulgation.
ADDENDUM <Presidential Decree No. 35250, Feb. 7, 2025>
This Decree shall enter into force on February 9, 2025; provided, the amended provisions of Article 13 (1) 13-5 shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 35669, Jul. 22, 2025>
This Decree shall enter into force on the date of its promulgation; provided, the amended provisions of Article 13-3 shall enter into force on August 1, 2025.