Article 50(Suspension of business) #
(1) If a manufacturer, etc. of digital medical devices, a manufacturer, etc. of digital convergence drugs, a person who has obtained permission by item for a digital convergence drug, or an importer of digital convergence drugs falls under any of the following cases, the Minister of Food and Drug Safety may revoke permission, certification, approval, or acceptance of notification, close the contract manufacturing and distribution business establishment or place of business (limited to an importer of digital convergence drugs notified pursuant to Article 30 (1); hereafter in Article 53 the same shall apply), issue an order to prohibit the manufacturing, import, or distribution of digital medical products, or order the suspension of all or part of business for a period not exceeding 1 year:
1. Where he or she has obtained permission or certification or filed a notification under Article 8 (1) or (3) or 12 (1) or (2) by fraud or other improper means;
2. Where he or she falls under any subparagraph of Article 8 (2) (including cases applied mutatis mutandis in Article 12 (4)); provided, this shall not apply where the heir transfers the status of a manufacturer of digital medical devices or importer of digital medical devices within 6 months pursuant to Article 47 (2) of the Medical Devices Act.;
3. Where he or she manufactures or imports a digital medical device without obtaining permission or certification or filing a notification, in violation of Article 8 (3) or 12 (2);
4. Where he or she fails to be equipped with facilities and manufacturing and quality management systems under the main clause of Article 8 (4) or facilities and quality management systems under the main clause of Article 12 (3);
5. Where he or she fails to appoint a quality manager, in violation of Article 8 (7) (including cases applied mutatis mutandis in Article 12 (4));
6. Where he or she has obtained approval or approval for change under Article 9 or 10 by fraud or other improper means;
7. Where he or she manufactures digital medical devices for a clinical study or clinical performance study in a manufacturing facility not in compliance with the standards or imports digital medical devices manufactured in such facility for a clinical study or clinical performance study, in violation of Article 9 (3) or 10 (2);
8. Where he or she fails to obtain permission for or certification of change or to file a notification of change, or fails to file a report on changed matters or files a false report, in violation of Article 11 (including cases applied mutatis mutandis in Article 12 (4));
9. Where he or she has obtained permission for or certification of change or certification of change or filed a notification of change under Article 11 (1) (including cases applied mutatis mutandis in Article 12 (4)) by fraud or other improper means;
10. Where he or she fails to comply with the matters to be observed, in violation of Article 13;
11. Where he or she fails to comply with security guidelines, in violation of Article 14 (2);
12. Where he or she fails to label or attach any of the matters referred to in the subparagraphs of Article 22 or who labels or attaches false information, in violation of Article 22;
13. Where he or she fails to obtain a certification of compliance or a certification of compliance for changes, in violation of Article 24 (2) or (3);
14. Where he or she ceases to meet the facility standards under Article 29 (1) or 30 (3);
15. Where he or she has obtained permission or permission for change or filed a notification or a notification of change under Article 29 (1), (2), or (6) by fraud or other improper means;
16. Where he or she fails to obtain permission by item, in violation of Article 29 (2) or (3);
17. Where he or she falls under any of Article 29 (5) 1 through 5 (in cases falling under subparagraph 5, limited to the importers of digital convergence drugs); provided, this shall not apply where the representative of a corporation falls under any of those provisions and is replaced within 6 months;
18. Where he or she falls under Article 29 (5) 6 or 30 (4) 2; provided, this shall not apply where the representative of a corporation falls under any of those provisions and is replaced within 6 months;
19. Where he or she fails to obtain permission or permission for change for each item or to file a notification or a notification of change for each item, in violation of Article 30 (1);
20. Where he or she obtains permission or permission for change or files a notification or a notification of change under Article 30 (1) by fraud or other improper means;
21. Where he or she fails to file for registration, registration of change, or notification of change, or files for registration, registration of change, or notification of change by fraud or other improper means, in violation of Article 30 (7) or (8);
22. Where he or she refuses, obstructs, or evades the entry, inspection, inquiry, questioning, or collection by a relevant public official under Article 49 (1);
23. Where he or she manufactures, imports, or distributes a digital medical product which poses or is likely to pose risk to public health or which is deemed non-functional, ineffective, or lacking efficacy;
24. Where he or she conducts business during the period of business suspension.
(2) The standards for administrative dispositions under paragraph (1) shall be prescribed by Prime Ministerial Decree.