Post-Market Safety Reporting Notification
The MFDS Adverse Event Reporting Notification (의료기기 이상사례 보고 및 안전대책에 관한 규정) provides detailed requirements for adverse event reporting and safety management.
Key provisions
- Definition of reportable events
- Reporting timeframes (15-day and 30-day)
- Reporting forms and submission portal details
- Investigation requirements after an event
- FSCA and recall notification requirements
- MFDS right to request additional information