How to Navigate Korean Regulatory Instruments
Key resourcesβ
| Resource | URL | Content |
|---|---|---|
| Korean Law Information Center | law.go.kr | Acts, Decrees, Rules in Korean (some English) |
| MFDS website | mfds.go.kr | Notifications (κ³ μ), 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 challengeβ
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)β
Acts β Enforcement Decrees β Enforcement Rules β MFDS Notifications (κ³ μ) β Guidance (κ°μ΄λλΌμΈ)
Notifications are updated most frequently to reflect technical developments.
Related pagesβ
Add under Language challenge section: "MFDS publishes English-language summaries and guidance for key documents (AI/ML devices, combination products, real-world evidence) on its English website (mfds.go.kr/en). These are reliable starting points; however, always cross-reference the Korean original for authoritative regulatory requirements."