How to Report โ MFDS Reporting Portal
Reporting portalโ
- URL: mdreport.mfds.go.kr
- Requires Korean business registration login; foreign manufacturers report via Korean importer/agent
Report contentโ
| Field | Detail |
|---|---|
| Reporter details | Manufacturer/importer name, contact, licence number |
| Product details | Product name, model, ํ๋ชฉํ๊ฐ number, lot/serial, UDI |
| Patient/user | Age, sex โ anonymised |
| Event description | What happened, when, how |
| Investigation findings | In follow-up report |
| Corrective actions | Taken or planned |
After submissionโ
MFDS assigns a report number, may request additional information, assesses whether recall action is triggered, and includes the data in national adverse event trend monitoring.