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 required before the device is supplied on the Korean market โ after obtaining ํ๋ชฉํ๊ฐ / ํ๋ชฉ์ ๊ณ and before placing the device in commerce.
Data to register for each Device Identifier (DI)โ
- Device Identifier (DI) value and issuing agency
- Product name
- ํ๋ชฉํ๊ฐ / ํ๋ชฉ์ ๊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
- ํ๋ชฉํ๊ฐ is modified
- Manufacturing site changes
- Device is discontinued (record must be archived)
Public accessโ
KIMS is publicly searchable at udiportal.mfds.go.kr.