How to Report — MFDS Reporting Portal
Reporting portal
- URL: mdreport.mfds.go.kr
- Requires Korean business registration login; foreign manufacturers report via Korean importer/agent
Report content
| Field | Detail |
|---|---|
| Reporter details | Manufacturer/importer name, contact, licence number |
| Product details | Product name, model, 품목허가 number, lot/serial, UDI |
| Patient/user | Age, sex — anonymised |
| Event description | What happened, when, how |
| Investigation findings | In follow-up report |
| Corrective actions | Taken or planned |
After submission
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.
Related pages
"Language
Reports must be submitted in Korean. Foreign manufacturers should coordinate with their Korean importer/agent to ensure proper translation and submission."