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
All dates shown are subject to change. Confirm current deadlines directly with MFDS via the UDI Portal (udiportal.mfds.go.kr) or by contacting the MFDS UDI helpline. Manufacturers should monitor MFDS website announcements at least quarterly.
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
Related pagesโ
Preparing for Phase 3 (Grade II)
Manufacturers with Grade II devices should:
- Review current device labelling and packaging
- Obtain a GS1 Company Prefix (if not already registered with GS1 Korea)
- Conduct an inventory of all Grade II devices and variants
- Plan label redesign and printing timelines
- Contact GS1 Korea early to avoid delays near the enforcement deadline