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UDI-K Compliance Deadlines by Device Grade — Unique Device Identification (Korea)

🇰🇷 South Korea (MFDS)📅 Key Date
Key Date

2027-07-01 — UDI-K Compliance Deadlines by Device Grade — Unique Device Identification (Korea)

MFDS is implementing UDI-K (Unique Device Identification — Korea) on a phased schedule by device grade:

  • Grade IV (highest risk): Mandatory UDI-K — deadline passed (2022)
  • Grade III: Mandatory UDI-K — deadline passed (2024)
  • Grade II: Mandatory UDI-K — confirm current deadline with MFDS
  • Grade I: Mandatory UDI-K — later implementation phase

UDI-K requires manufacturers to:

  • Assign a UDI-DI and UDI-PI using an MFDS-recognised issuing agency.
  • Label devices with the UDI in human-readable and machine-readable (barcode/GS1 DataMatrix) format.
  • Register UDI data in the KIMS (Korea Integrated Medical Supplies) database.

Manufacturers with Grade I or II devices supplying the Korean market should confirm the current mandatory UDI-K compliance deadline for their device grade directly with MFDS or their Korean importer, as dates are updated periodically.

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