Article 36(Revocation of permission, suspension of business activities, and relevant matters) #
(1) If any of the following events occurs to a manufacturer, etc. or a medical device sales promoter, the relevant permission, certification, approval, or acceptance of notification may be revoked, the place of business may be closed, the manufacturing, import, and distribution of the relevant item category or item may be prohibited, or an order to suspend business activities completely or partially for up to a year may be issued, by the Minister of Food and Drug Safety if the person is a manufacturer or importer of the medical device or a person who is approved for clinical trials under Article 10, and by the Special Self-Governing City Mayor, the Special Self-Governing Province Governor, or the head of a Si/Gun/Gu if the person is a repairer, a distributor, or a lessor of the medical device, or a medical device sales promoter; provided, the relevant permission, certification, approval, or acceptance of notification shall be revoked or the place of business shall be closed, in cases falling under subparagraph 1, 1-2 through 1-4, 22, or 23: <Amended on Mar. 23, 2013; Aug. 13, 2013; Jan. 28, 2015; Dec. 2, 2016; Dec. 19, 2017; Dec. 11, 2018; Feb. 18, 2020; Jul. 20, 2021; Aug. 17, 2021; Aug. 8, 2023; Oct. 22, 2024>
1. If any of the subparagraphs of Article 6 (1) is applicable [in cases of a distributor, lessor, or medical device sales promoter, limited to cases falling under Article 6 (1) 2 (in cases of a medical device sales promoter, limited to cases of a person under adult guardianship or person under limited guardianship), 4, 4-2, and 5]; provided, this shall not apply if the heir transfers the status of a manufacturer, etc. or a medical devices sales promoter within 6 months under Article 47 (2);
1-2. Where a manufacturer, etc. obtains permission, permission for change, certification, or certification for change or files a notification or a notification on change under Article 6 (1) or (2), 12 (1) (including cases applied mutatis mutandis under Article 15 (6), 16 (4), or 17 (3)), 15 (1) or (2), 16 (1), 17 (1), or 18-2 (1) by fraud or other improper means;
1-3. Where a manufacturer, etc. obtains approval or approval for change under Article 10 (1) by fraud or other improper means;
1-4. Where a manufacturer, etc. obtains renewal under Article 49 (3) by fraud or other improper means;
2. Where a manufacturer, etc. manufactures or imports a medical device without obtaining permission or certification, or filing a notification, in violation of Article 6 (2) or 15 (2);
3. Where a manufacturer, etc. fails to be equipped with facilities and manufacturing and quality management systems under the main clauses of Article 6 (4) and Article 15 (4), or facilities and manufacturing and quality management systems under the main clause of Article 16 (2);
3-2. Where a manufacturer, etc. fails to have a quality manager, in violation of Article 6 (7) (including cases applied mutatis mutandis under Article 15 (6));
3-3. Where a manufacturer, etc. requires a quality manager who has not received training to perform the duties, in violation of Article 6-2 (4) (including cases applied mutatis mutandis under Article 15 (6));
4. Where a manufacturer, etc. fails to fulfill any of the conditions imposed under Article 7 (1);
5. Where a manufacturer, etc. fails to conduct the post market surveillance, in violation of Article 8;
5-2. Where a manufacturer, etc. fails to obtain approval or approval for change, or fails to observe the plan for surveillance approved or approved for change, in violation of Article 8 (3);
5-3. Where a manufacturer, etc. fails to file a report regularly or files a report by fraud or other improper means, in violation of Article 8 (4);
5-4. Where a manufacturer, etc. fails to fulfill the order to take measures under Article 8 (5);
5-5. Where a manufacturer, etc. fails to secure safety or effectiveness, based on the results of review under Article 8-2;
5-6. Where a manufacturer, etc. fails to submit data within the deadline or submits data by fraud or other improper means, in violation of Article 8-2 (1);
5-7. Where a manufacturer, etc. fails to fulfill the order to take measures under Article 8-2 (2);
5-8. Where a manufacturer, etc. fails to comply with matters concerning the retaining of data, in violation of Article 8-2 (3);
6. Where a manufacturer, etc. fails to undergo a re-evaluation or take measures required based on the results of a re-evaluation in violation of Article 9, or is found, as a result of a re-evaluation, to have failed to secure safety or effectiveness;
7. Where a manufacturer, etc. manufactures medical devices in a manufacturing facility not in compliance with standards or imports medical devices manufactured in such a facility, in violation of Article 10 (2);
8. Where a manufacturer, etc. fails to obtain permission or certification for change or file a notification on change, in violation of Article 12 (1) (including cases to which Article 12 (1) shall apply mutatis mutandis under Article 15 (6), 16 (4), or 17 (3));
9. Where a manufacturer, etc. fails to comply with any of the matters to be observed in relation to manufacturing, quality management, production management, import management, or repair management, in violation of Article 13 (1) (including cases to which Article 13 (1) shall apply mutatis mutandis under Article 15 (6) or 16 (4));
9-2. Where a manufacturer, etc. fails to report the results of production or import, etc. of medical devices, in violation of Article 13 (2) (including cases applied mutatis mutandis in Article 15 (6));
10. Where a manufacturer, etc. provides any economic benefit, etc., in violation of Article 13 (3) (including cases to which Article 13 (3) shall apply mutatis mutandis under Article 15 (6)) or Article 18 (2);
11. Where a manufacturer, etc. fails to comply with the maintenance of order in distribution and other relevant matters, in violation of Article 18 (1);
11-2. Where a manufacturer, etc. fails to meet the standards for notification under Article 18-2 (1);
11-3. Where a manufacturer, etc. requires a person engaged in the promotion of distribution of medical devices who has failed to receive education, to engage in such affairs, in violation of Article 18-3 (1);
11-4. Where a manufacturer, etc. fails to inform the manufacturer, importer, distributor, or lessor who entrusted the relevant affairs in writing (including electronic documents defined in subparagraph 1 of Article 2 of the Framework Act on Electronic Documents and Transactions) of the fact that all or part of the affairs of promoting the distribution or lease of medical devices has been re-entrusted, in violation of Article 18-4 (1);
11-5. Where a manufacturer, etc. opens a sealed container or package of a medical device and distributes it, in violation of Article 18-5;
12. Where a manufacturer, etc. commits a violation in labeling any matters under Articles 20 through 23;
13. Where a manufacturer, etc. violates Article 24 (1) or (3) in labeling or placing a description in a container, an outer package, packing material, or a package insert of a medical device;
14. Where a manufacturer, etc. makes an advertisement of a medical device in violation of Article 24 (2) or (3);
14-2. Where a manufacturer, etc. distributes a medical device without sealing its container or package, in violation of Article 25-5;
14-3. Where a manufacturer, etc. fails to comply with the matters to be observed under Article 26;
14-4. Where a manufacturer, etc. fails to prepare, preserve, or submit records or prepares, preserves, or submits false records, in violation of Article 30 (1);
15. Where a manufacturer, etc. disobeys an order for submission of data, etc. without just cause in violation of Article 30 (2);
16. Where a manufacturer, etc. fails to report an occurrence of a side effect or fails to retain the records of an occurrence of a side effect, in violation of Article 31 (1);
17. Where a manufacturer, etc. fails to recall medical devices, fails to take measures necessary for recall or fails to report a recall plan, in violation of Article 31 (2), or fails to comply with an order to publicly announce such a recall plan, in violation of paragraph (3) of said Article;
17-2. Where a manufacturer, etc. fails to report details of provision of medical devices or falsely reports thereon, in violation of Article 31-2 (1);
17-3. Where a manufacturer, etc. fails to register information with the integrated medical device information system, in violation of Article 31-3 (2), or fails to comply with the standard for managing integrated medical device information, in violation of Article 31-3 (3);
18. Where a manufacturer, etc. fails to report the detection of a foreign substance or files a false report thereon, in violation of Article 31-5;
19. Where a manufacturer, etc. refuses, interferes with, or evades the entry, inspection, inquiry, or collection by a relevant public official under Article 32 (1);
20. Where a medical device handled by a manufacturer, etc. is found, as a result of an inspection conducted under Article 32 or 33, to have caused, or to be likely to cause, risk to the public health;
21. Where a manufacturer, etc. fails to comply with any order issued under Article 33, 34, or 35;
21-2. Where a manufacturer, etc. fails to purchase an insurance policy, etc., in violation of Article 43-6;
22. Where a manufacturer, etc. manufactures, imports, repairs, sells, or leases a medical device that has caused, or is likely to cause, risk to public health, or a medical device deemed not having the claimed performance, efficacy, or effect;
23. Where a manufacturer, etc. has no facility or place of business at the location permitted or notified in accordance with this Act;
24. Where a manufacturer, etc. continues his or her business during a period for which his or her business activities are suspended.
25. Where a manufacturer, etc. manufactures or imports a medical device, for which the validity period of manufacturing permission, etc. has expired, without having the manufacturing permission, etc. renewed, in violation of Article 49 (3), or fails to fulfill the conditions attached at the time of renewal under paragraph (4) of the same Article.
(2) Notwithstanding paragraph (1), if the relevant manufacturer or importer is not culpable for the cause in question in the cases falling under paragraph (1) 5-5 and 6 (limited to cases where it is found, as a result of a re-evaluation, to have failed to secure safety or effectiveness) and it is deemed that the purpose of the relevant permission, certification, or notification can be achieved by changing the raw material or structure, etc. of the medical device, an order for such change only may be issued. <Amended on Jan. 28, 2015; Dec. 11, 2018; Aug. 17, 2021>
(3) If a person fails to comply with an order for change under paragraph (2), the Minister of Food and Drug Safety may also issue any of the administrative dispositions under paragraph (1). <Amended on Mar. 23, 2013>
(4) In cases falling under paragraph (1) 18, the Minister of Health and Welfare may request the Minister of Food and Drug Safety to issue an order revoking the relevant permission or certification, closing the place of business, prohibiting the manufacture, import, or distribution of the item category or the item, or suspending the business activities. <Amended on Mar. 23, 2013; Jan. 28, 2015>
(5) The criteria for the administrative dispositions under paragraphs (1) through (3) shall be prescribed by Prime Ministerial Decree. <Added on Mar. 23, 2013>
[Deleting the part of the case of advertising a medical device in violation of Article 24 (2) 6 in Article 36 (1) 14, which was determined unconstitutional by the Constitutional Court on Aug. 28, 2020 under Act No. 17978 on Mar. 23, 2021]