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

Related pages

• Adverse event reporting — what must be reported · How to report