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
The purpose of this Decree is to prescribe matters mandated by the Medical Devices Act and matters necessary for the enforcement thereof.
| Article 2 Deleted. <Oct. 22, 2019> |
| 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 Medical Devices Act (hereinafter referred to as 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> |
| 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 the member is or was in a familial relation with 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 the member or the corporation or organization to which the member belongs is or was an agent of 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 the member has any substantial ground that impedes the fair investigation 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 Newly Inserted 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. | The member engages in any misconduct in relation to 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. | The member voluntarily admits that it is impracticable for him or her 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 Newly Inserted 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. <Newly Inserted 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. <Newly Inserted 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. <Newly Inserted 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 under Article 6, and research expenses and travel expenses for surveys, research, etc. to research members and researchers, respectively, within budgetary limits. <Amended on Feb. 29, 2008; Mar. 15, 2010; Mar. 23, 2013>
| Article 10-2 (Matters to be Observed by Distributors and Lessors) |
| 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 Ordinance of the Prime Minister; |
| 2. | Except as provided in subparagraph 1, matters concerning the maintenance of order in distribution, and so on, which are prescribed by Ordinance of the Ministry of Health and Welfare. |
[This Article Newly Inserted on Mar. 23, 2013]
| Article 10-3 (Media subject to Voluntary Deliberation of Advertisements) |
| 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: |
[This Article Newly Inserted 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, etc. 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, That 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 Ordinance of the Prime Minister 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, That 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 Newly Inserted on Jun. 15, 2021]
| Article 10-5 (Organization of Voluntary Deliberation Agency) |
| (1) | "Institution or organization meeting the standards prescribed by Presidential Decree" in Article 25-2 (1) 1 of the Act means an institution or organization related to medical devices whose member, such as an employee or a member of association, comprised of a manufacturer, an importer, a repairer, a distributer, or a lessor of a medical device. |
| (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 Articles 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 Ordinance of the Prime Minister 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 Newly Inserted 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"); |
| 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 Newly Inserted on Aug. 1, 2017]
[Moved from Article 10-3 <Jun. 15, 2021>]
| (a) | Medical devices of Class 4: July 1, 2020; |
| (b) | Medical devices of Class 3: July 1, 2021; |
| (c) | Medical devices of Class 2: July 1, 2022; |
| (d) | Medical devices of Class 1: July 1, 2023. |
| (a) | Medical devices of Class 4: July 1, 2019; |
| (b) | Medical devices of Class 3: July 1, 2020; |
| (c) | Medical devices of Class 2: July 1, 2021; |
| (d) | Medical devices of Class 1: July 1, 2022. |
| 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 attached Table 1, in accordance with the criteria for business suspension disposition prescribed by Ordinance of the Prime Minister 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, That 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 Newly Inserted 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 Articles 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) | A person in receipt of the notification under paragraph (1) shall pay the penalty surcharge to a collecting agency designated by 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, within 20 days from the receipt of the notification: Provided, That if the person is unable to pay the penalty surcharge within the specified period due to a natural disaster or any other unavoidable cause, he or she shall pay it within seven days from the date such cause ceases to exist. <Amended on Mar. 23, 2013; May 21, 2019> |
| (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, That 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 Newly Inserted 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 Newly Inserted 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 Newly Inserted on Oct. 7, 2011]
[Title Amended on Sep. 11, 2018]
[Moved from Article 12-3 <May 21, 2019>]
| 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> |
| 2. | Deleted; <Jun. 30, 2015> |
| 4. | Deleted; <Jun. 30, 2015> |
| 5. | Deleted; <Jun. 30, 2015> |
| 7. | Acceptance of notification on permanent closure, temporary closure, resumption, and changes under Article 14 of the Act; |
| 9. | Deleted; <Jun. 30, 2015> |
| 11. | Deleted; <Jun. 30, 2015> |
| 16. | Orders for suspension of sale, recall, destruction, or other measures and orders for public announcement under Article 34 (1) 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; |
| 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; |
| (2) | Deleted. <Sep. 8, 2020> |
[This Article Wholly Amended on Oct. 7, 2011]
| (a) | Medical devices of Class 4: July 1, 2020; |
| (b) | Medical devices of Class 3: July 1, 2021; |
| (c) | Medical devices of Class 2: July 1, 2022; |
| (d) | Medical devices of Class 1: July 1, 2023. |
| (a) | Medical devices of Class 4: July 1, 2019; |
| (b) | Medical devices of Class 3: July 1, 2020; |
| (c) | Medical devices of Class 2: July 1, 2021; |
| (d) | Medical devices of Class 1: July 1, 2022. |
| 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, information falling under criminal history records under subparagraph 2 of Article 18 of the Enforcement Decree of the same Act (limited to information violating statues concerning medical devices) or resident registration numbers or foreigner registration numbers prescribed in Article 19 of the same Decree, to perform the following affairs: <Amended on Mar. 23, 2013; Jun. 30, 2015; Aug. 1, 2017; May 21, 2019> | 2. | Affairs related to conditional manufacturing business approvals, etc. under Article 7 of the Act; |
| 3. | Affairs related to approval of amendment to manufacturing business approvals, etc. under Article 12 of the Act; |
| 4. | Affairs related to notification of manufacturers on temporary shutdown, permanent closure, resumption, and changes under Article 14 of the Act; |
| 5. | 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. | 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. | 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. | 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; |
| 7-3. | 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 pursuant to Article 31 of the Act; |
| 8. | 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; |
| 12. | Affairs related to the appointment of medical device surveillance officers of medical devices under Article 40 of the Act; |
| 14. | Affairs related to the renewal of an approval, certification, or notification acceptance letter under Article 49 of the Act. |
[This Article Newly Inserted 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 attached Table 2. [This Article Newly Inserted 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.
Article 2 Omitted.
ADDENDA <Presidential Decree No. 19513, Jun. 12, 2006>
Article 1 (Enforcement Date)
This Decree shall enter into force on July 1, 2006.
Articles 2 through 4 Omitted.
ADDENDUM <Presidential Decree No. 20157, Jul. 3, 2007>
This Decree shall enter into force on July 4, 2007: Provided, That 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 force on the date of its promulgation.
Articles 2 through 9 Omitted.
ADDENDA <Presidential Decree No. 22075, Mar. 15, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on March 19, 2010. (Proviso Omitted.)
Article 2 Omitted.
ADDENDA <Presidential Decree No. 22247, Jun. 30, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on January 1, 2011: Provided, That the amended provisions of Article 7 shall enter into force on the date of its promulgation. Article 2 (Transitional Measures concerning Dispositions, etc.)
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, That 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, etc.)
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 attached Table 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 attached Tale 2. |
ADDENDA <Presidential Decree No. 23488, Jan. 6, 2012>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Article 2 Omitted.
ADDENDA <Presidential Decree No. 24480, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into force 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, etc. 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 provisons 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 provisons 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.
Article 2 Omitted.
ADDENDA <Presidential Decree No. 26375, Jun. 30, 2015>
Article 1 (Enforcement Date)
This Decree shall enter into force on July 29, 2015: Provided, That the amended provisions of Article 12-2 (2) and Table 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/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 force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 27209, May 31, 2016>
This Decree shall enter into force 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 force on the date of its promulgation.
ADDENDA <Presidential Decree No. 30545, Mar. 24, 2020>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Article 2 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.
Articles 2 through 3 Omitted.
ADDENDUM <Presidential Decree No. 31380, Nov. 5, 2021>
This Decree shall enter into force 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.
Article 2 Omitted.
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.)
Article 2 Omitted.
ADDENDUM <Presidential Decree No. 32348, Jan. 18, 2022>
This Decree shall enter into force on January 21, 2022: Provided, That the amended provisions of attached Table 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.