South Korea Medical Device Regulations
The South Korean MFDS reviews and updates these documents frequently throughout the year. For the most current copies of the regulations please refer to the government website. All PDFs will be in Korean. Please contact us with any questions.
Major Regulations
| Document | Language | Number | Published |
|---|---|---|---|
| Enforcement Decree of the Medical Devices Act - Attached Table | ko | Presidential Decree No. 24480 | 03/2013 |
| Enforcement regulation of the Medical Device Act with attached table | ko | Ministerial Decree No. 1016 | 03/2013 |
| KGMP quality management system compliance with attached table | ko | MFDS Notification No. 2013-219 | 09/2013 |
| Medical Devices Act | en ko | Act No.13116 | 2015 |
| Regulation for Medical Device Approval, Notification, Review with attached table | ko | MFDS Notification No. 2019-13 | 02/2019 |
| Regulations for Management of Safety Information on Medical Devices including Adverse Event Reporting, etc.with attached table | ko | MFDS Notification No. 2013-62 | 04/2013 |
| Regulations for Prior Review of Medical Device Advertisement with attached table | ko | MFDS Notification No. 2013-189 | 06/2013 |
| Regulations for Re-evaluation of Medical Device | en | MFDS Notification No. 2013-67 | 04/2013 |
| Regulations for Re-examination of Medical Device with attached table | ko | MFDS Notification No. 2013-66 | 04/2013 |
| Regulations for Reviewing Technical Document, etc. of Medical Device - Attached Table | ko | KR-001 | - |
| Regulations for Reviewing Technical Document, etc. of Medical Device | ko | KFDA Notification No. 2010-42 | 6/2010 |
Specific Guidance Documents
| Document | Language | Number | Published |
|---|---|---|---|
| Designation of Medical Device Subject to Tracking | ko | MFDS Notification No. 2013-169 | 4/2013 |
| Detailed operational GMP guideline for foreign manufacturers of imported medical devices | ko | Rev. 1 | 2013 |
| Regulations for Designation of Technical Document Review Organization for Medical Device | ko | MFDS Notification No. 2013-212 | 08/2013 |
| Regulations for Management of Clinical Trial for Medical Device | ko | MFDS Notification No. 2013-211 | 08/2013 |
| Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device - Attached Table | ko | KR-002 | 09/2014 |
| Regulations for Performance Report on Production, Export, Import and Refurbishing of Medical Device | ko | MFDS Notification No. 2013-63 | 04/2013 |
| Regulations for Product Classifications of Medical Devices and Class by Product | ko | MFDS Notification No. 2016-4 | 02/2016 |
| Regulations on Approving Clinical Investigation Plan for Medical Device | ko | MFDS Notification No. 2013-53 | 04/2013 |
Forms and Applications
| Document | Language | Number | Published |
|---|---|---|---|
| Application for Designation of an Orphan Device - Attached Form | ko | KR-003 | 04/2013 |
| Application for Designation of an Orphan Device | ko | MFDS Notification No. 2013-71 | 04/2013 |
| Regulations for Prior Review of Medical Device Advertisement - Attached Form | ko | KR-004 | 09/2014 |