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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 registerโ€‹

Registration in KIMS is mandatory before the device is supplied on the Korean market. Timing: After obtaining ํ’ˆ๋ชฉํ—ˆ๊ฐ€ (licensing approval) or ํ’ˆ๋ชฉ์‹ ๊ณ  (notification registration) and before placing the device in commerce or entering warehouses for distribution.

Data to register for each Device Identifier (DI)โ€‹

  • Device Identifier (DI) value and issuing agency
  • Product name
  • ํ’ˆ๋ชฉํ—ˆ๊ฐ€ / ํ’ˆ๋ชฉ์‹ ๊ณ  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 recordsโ€‹

KIMS records must be kept current. Updates required when:

  • Product name or description changes
  • ํ’ˆ๋ชฉํ—ˆ๊ฐ€ is modified
  • Manufacturing site changes
  • Device is discontinued (record must be archived)

Public accessโ€‹

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

Update timelines

KIMS record updates must be submitted:

  • Within 30 days of obtaining ํ’ˆ๋ชฉํ—ˆ๊ฐ€ / ํ’ˆ๋ชฉ์‹ ๊ณ  modification
  • Before changes to manufacturing site take effect
  • Immediately upon device discontinuation

Failure to maintain current KIMS records may result in regulatory action or market suspension. Confirm current timelines with MFDS.