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UDI Notification

The MFDS UDI Notification (의료기기 κ³ μœ μ‹λ³„μž μ‹œμŠ€ν…œ μš΄μ˜μ— κ΄€ν•œ κ·œμ •) 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)