UDI Notification
The MFDS UDI Notification (의료기기 고유식별자 시스템 운영에 관한 규정) sets out requirements for the UDI-K system and KIMS registration.
Key provisions
- UDI-K structure (Device Identifier + Production Identifier)
- Which devices require UDI labelling and KIMS registration
- Phased compliance timeline by device grade
- KIMS registration process and required data elements
- Authorised issuing agencies (GS1 Korea, HIBCC)