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KIMS Database Registration and Maintenance

KIMS (Korea Integrated Medical-device System) is the national database maintained by MFDS holding UDI-K registration information for all devices on the Korean market.

When to register​

Registration in KIMS is mandatory before the device is supplied on the Korean market. Timing: After obtaining 품목허가 (licensing approval) or 품목신고 (notification registration) and before placing the device in commerce or entering warehouses for distribution.

Data to register for each Device Identifier (DI)​

  • Device Identifier (DI) value and issuing agency
  • Product name
  • 품목허가 / 품목신고 number
  • Manufacturer details and manufacturing site
  • Device description and intended use
  • Sterility, reuse, and implant status
  • MRI safety information (if applicable)
  • Device variants / configurations

Maintaining KIMS records​

KIMS records must be kept current. Updates required when:

  • Product name or description changes
  • 품목허가 is modified
  • Manufacturing site changes
  • Device is discontinued (record must be archived)

Public access​

KIMS is publicly searchable at udiportal.mfds.go.kr.