조문단위인쇄

ENFORCEMENT DECREE OF THE MEDICAL DEVICES ACT
조문단위인쇄
 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 by Presidential Decree No. 24480, Mar. 23, 2013; Presidential Decree No. 26375, Jun. 30, 2015; Presidential Decree No. 27209, May 31, 2016; Presidential Decree No. 28224, Aug. 1, 2017>
1. Approval for manufacturing business under Article 6 (1) of the Act;
2. Deleted; <by Presidential Decree No. 26375, Jun. 30, 2015>
3. Conditional approval for manufacturing business under Article 7 of the Act;
4. and 5. Deleted; <by Presidential Decree No. 26375, 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; <by Presidential Decree No. 26375, 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; <by Presidential Decree No. 26375, 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;
14. Orders to report, and entry, inspection, inquiries, and collection under Article 32 of the Act;
15. Inspection orders under Article 33 of the Act;
16. Orders to recall or destroy medical devices, take other measure, and make public announcements 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) The Minister of Food and Drug Safety shall delegate the following authority over repairers of medical devices to the Special Metropolitan City Mayor, Metropolitan City Mayors, Do Governors, and Special Self-Governing Province Governor pursuant to Article 44 of the Act: <Amended by Presidential Decree No. 24480, Mar. 23, 2013; Presidential Decree No. 28224, Aug. 1, 2017>
1. Acceptance of reports on repair business under Article 16 (1) of the Act;
2. Acceptance of amendment to reports on repair business under Article 12 of the Act, which is applied mutatis mutandis under Article 16 (4) of the Act;
3. Acceptance of notification on permanent closure, temporary closure, resumption, and changes under Article 14 of the Act, which is applied mutatis mutandis under Article 16 (4) of the Act;
4. Orders to report, and entry, inspection, inquiries, and collection under Article 32 of the Act;
5. Inspection orders under Article 33 of the Act;
6. Orders to recall or destroy medical devices, take other measures, or make public announcements under Article 34 (1) of the Act;
7. Orders to destroy, envelop, or seal goods at issue or take other necessary measures under Article 34 (2) of the Act;
8. Orders to suspend the use of, or repair, a medical device, or take other necessary measures under Article 35 of the Act;
9. Closure of business places and suspension of business activities under Article 36 of the Act;
10. Imposition and collection of penalty surcharges under Article 38 of the Act;
11. Hearings on closure of business places and suspension of business activities under Article 39 of the Act;
12. Renewal of notification acceptance letters under Article 49 of the Act;
13. Collection of fees under Article 50 of the Act;
14. Imposition and collection of administrative fines under Article 56 (1) 2 and Article 56 (1) 2-3 of the Act.
[This Article Wholly Amended by Presidential Decree No. 23200, Oct. 7, 2011]
<<Enforcement Date of Article 13 : Unconfirmed>>