How to Navigate Korean Regulatory Instruments
Key resources
| Resource | URL | Content |
|---|---|---|
| Korean Law Information Center | law.go.kr | Acts, Decrees, Rules in Korean (some English) |
| MFDS website | mfds.go.kr | Notifications (고시), guidance, news |
| MFDS eSubmission portal | emed.mfds.go.kr | Applications, submissions |
| KIMS / UDI Portal | udiportal.mfds.go.kr | Classification table, UDI-K database |
| Korean Standards Association | ksa.or.kr | KS standards |
Language challenge
Most Korean regulatory instruments are only available in Korean. Official English translations are from MFDS limited to select guidance documents and IMDRF-aligned materials. Strategies:
- Use DeepL or Google Translate as a starting point, then verify with a qualified Korean regulatory consultant
- English summaries are sometimes published by MFDS for IMDRF-aligned documents
Legislative hierarchy (highest to lowest)
Acts → Enforcement Decrees → Enforcement Rules → MFDS Notifications (고시) → Guidance (가이드라인)
Notifications are updated most frequently to reflect technical developments.