South Korea Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for South Korea.
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | Medical Devices Act | Act No.13116 | 2015 | English |
| Download | Regulations for Re-evaluation of Medical Device | MFDS Notification No. 2013-67 | 04/2013 | English |
| Download | Regulation for Medical Device Approval, Notification, Review with attached table | MFDS Notification No. 2019-13 | 02/2019 | Korean |
| Download | Medical Devices Act | Act No.13116 | 2015 | Korean |
| Download | Regulations for Reviewing Technical Document, etc. of Medical Device - Attached Table | KR-001 | - | Korean |
| Download | Regulations for Prior Review of Medical Device Advertisement with attached table | MFDS Notification No. 2013-189 | 06/2013 | Korean |
| Download | Regulations for Management of Safety Information on Medical Devices including Adverse Event Reporting, etc.with attached table | MFDS Notification No. 2013-62 | 04/2013 | Korean |
| Download | Regulations for Re-examination of Medical Device with attached table | MFDS Notification No. 2013-66 | 04/2013 | Korean |
| Download | Regulations for Reviewing Technical Document, etc. of Medical Device | KFDA Notification No. 2010-42 | 6/2010 | Korean |
| Download | Enforcement Decree of the Medical Devices Act - Attached Table | Presidential Decree No. 24480 | 03/2013 | Korean |
| Download | Enforcement regulation of the Medical Device Act with attached table | Ministerial Decree No. 1016 | 03/2013 | Korean |
| Download | KGMP quality management system compliance with attached table | MFDS Notification No. 2013-219 | 09/2013 | Korean |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | Regulations for Product Classifications of Medical Devices and Class by Product | MFDS Notification No. 2016-4 | 02/2016 | Korean |
| Download | Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device - Attached Table | KR-002 | Korean | |
| Download | Regulations on Approving Clinical Investigation Plan for Medical Device | MFDS Notification No. 2013-53 | 04/2013 | Korean |
| Download | Regulations for Management of Clinical Trial for Medical Device | MFDS Notification No. 2013-211 | 08/2013 | Korean |
| Download | Designation of Medical Device Subject to Tracking | MFDS Notification No. 2013-169 | 4/2013 | Korean |
| Download | Regulations for Designation of Technical Document Review Organization for Medical Device | MFDS Notification No. 2013-212 | 08/2013 | Korean |
| Download | Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device | MFDS Notification No. 2013-63 | 04/2013 | Korean |
| Download | Detailed operational GMP guideline for foreign manufacturers of imported medical devices | Rev. 1 | 2013 | Korean |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | Regulations for Prior Review of Medical Device Advertisement - Attached Form | KR-004 | Korean | |
| Download | Application for Designation of an Orphan Device - Attached Form | KR-003 | 04/2013 | Korean |
| Download | Application for Designation of an Orphan Device | MFDS Notification No. 2013-71 | 04/2013 | Korean |
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