Periodic Safety Update Reporting
Holders of Grade III and IV 품목허가 must submit periodic safety reports to MFDS summarising post-market safety experience.
Reporting frequency
Specified by MFDS — typically annually for the first few years post-approval, then every 2–3 years for established devices.
Report content
- Summary of all adverse events reported during the period
- Analysis of PMS data (literature, registry data, complaints)
- International regulatory actions (foreign recalls, safety alerts)
- Assessment of the benefit-risk balance
- Proposed actions if a safety signal is identified