What is KIMS?
KIMS (Korea Integrated Medical-device System, μλ£κΈ°κΈ° ν΅ν© μ 보 μμ€ν ) is the national database maintained by MFDS serving as the central registry for medical devices on the Korean market.
KIMS functionsβ
| Function | Description |
|---|---|
| UDI-K registration | Mandatory registration of Device Identifiers and device attributes |
| Product database | Searchable database of all νλͺ©νκ° / νλͺ©μ κ³ 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 KIMSβ
- Manufacturers/importers β via MFDS eSubmission portal to submit and manage device records
- Public β searchable at udiportal.mfds.go.kr