Periodic Safety Update Reporting
Holders of Grade III and IV ํ๋ชฉํ๊ฐ must submit periodic safety reports to MFDS summarising post-market safety experience.
Reporting frequencyโ
Specified by MFDS โ typically annually for the first few years post-approval, then every 2โ3 years for established devices.
Report contentโ
- 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