Upcoming Enforcement Dates
Key upcoming compliance datesโ
| Date | Requirement | Applies to |
|---|---|---|
| TBD (2025โ2026) | UDI-K Phase 3 โ Grade II | All Grade II devices |
| TBD | UDI-K Phase 4 โ Grade I | All Grade I devices |
| Annually | KGMP certificate renewal | Manufacturers with certificates due |
| Re-examination period end | ์ฌ์ฌ์ฌ application deadline | Grade III/IV first approvals within their re-examination period |
note
Confirm all dates with MFDS โ the schedule may be updated.
How to track your specific datesโ
- Check your ํ๋ชฉํ๊ฐ certificate for the re-examination period end date
- Check your KGMP certificate validity period
- Monitor MFDS website for UDI-K phased deadline announcements