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Product Database — Submitting and Updating Records

Initial submission​

After obtaining 품목허가 or 품목신고, register the device in KIMS via the MFDS eSubmission portal before placing it on the market.

Required data elements:

  • Product name and description
  • 품목허가 / 품목신고 number and date
  • Device grade and classification code
  • Manufacturer details
  • UDI-K Device Identifier (DI) — once assigned
  • Key device attributes (sterility, implantable status, reuse, etc.)

When to update records​

KIMS records must be updated when:

  • Product name or description changes
  • New models or variants added
  • Manufacturing site changes (following 변경허가/신고)
  • Product is discontinued (record must be closed/archived)
  • 품목허가 is modified

Common KIMS Submission Issues​

When submitting or updating KIMS records via the MFDS eSubmission portal, ensure:

  • All required data fields are complete and match official 품목허가/품목신고 documents
  • Device classification codes align with MFDS classification guidelines
  • UDI-K Device Identifier (DI) format is correct (GS1 or HIBCC issued)
  • Manufacturer details match the official registration

Incomplete or inaccurate submissions will be rejected by the MFDS portal and must be corrected before resubmission.