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 |
:::Important: Grade II and Grade I timelines (marked "TBD") have not been officially confirmed by MFDS. Manufacturers should monitor MFDS notifications and the UDI portal (udiportal.mfds.go.kr) for updates. Early planning is recommended even before official deadlines are announced. :::
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.
Related pages
Enforcement and Penalties
Failure to comply with UDI-K requirements by the applicable deadline may result in:
- MFDS issuing a warning notice (경고)
- Suspension of product sales authorization (판매 중지)
- Administrative fines or penalties
- Removal from KIMS database
Manufacturers and importers should plan compliance activities well in advance of the deadline to avoid disruption to supply chains.