UDI-K Compliance Timeline by Grade
Compliance timeline
| Grade | UDI-K labelling required from | KIMS registration required from |
|---|---|---|
| Grade IV | January 2022 | January 2022 |
| Grade III | January 2024 | January 2024 |
| Grade II | TBD (expected 2025–2026) | TBD |
| Grade I | TBD | TBD |
note
Confirm current dates with MFDS — the schedule may be updated.
What "compliance" means by the applicable date
- DI obtained from an issuing agency (GS1 Korea or HIBCC)
- Device registered in KIMS with all required data
- UDI-K labels applied to all units distributed in Korea from that date
Existing stock at compliance date
MFDS may allow a transition period for existing stock. Check the relevant MFDS notification for specific transition provisions.