South Korea Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for South Korea.
Related resources:
- Medical Device Registration in South Korea
- South Korea Approval Process for Medical Devices
- South Korea’s Ministry of Food and Drug Safety
Related services for South Korea:
- Korea Good Manufacturing Practice (KGMP) for medical device manufacturers
- South Korea License Holder for MFDS (KFDA)
- Medical Device Classification in South Korea
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Enforcement Regulations of the MDA | English | ||
| Log in | Regulations on IVD Medical Device Approval, Notification, Examination, etc. | Korean | ||
| Log in | Enforcement Regulations of the IVD Act | Korean | ||
| Log in | In Vitro Diagnostic (IVD) Medical Devices Act (IVD Act) | Korean | ||
| Log in | Regulation for Medical Device Approval, Notification, Review | MFDS Notification No. 2019-13 | 02/2019 | Korean |
| Log in | Medical Devices Act | Act No.13116 | 2015 | Korean |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Regulations on In Vitro Medical Device Codes and Classification | Korean | ||
| Log in | Regulations on Medical Device Codes and Classification | Korean | ||
| Log in | IVD Medical Device Manufacturing and Quality Control Standards | Korean | ||
| Log in | Medical Device Manufacturing and Quality Control Standards | Korean |
