What is KIMS?
KIMS (Korea Integrated Medical-device System, 의료기기 통합 정보 시스템) is the national database maintained by MFDS serving as the central registry for medical devices on the Korean market.
KIMS functions
| Function | Description |
|---|---|
| UDI-K registration | Mandatory registration of Device Identifiers and device attributes |
| Product database | Searchable database of all 품목허가 / 품목신고 products |
| Adverse event link | Links device identity to adverse event records |
| Recall tracking | Enables MFDS to track recalls by DI and lot number |
| Public transparency | Healthcare facilities and patients can search to verify devices |
Access to KIMS
- Manufacturers/importers — via MFDS eSubmission portal to submit and manage device records
- Public — searchable at udiportal.mfds.go.kr