PMS Plan and Report Requirements
Manufacturers and importers of Grade III and IV devices (and IVD Grades C/D) must maintain a Post-Market Surveillance (PMS) system.
PMS plan must specifyโ
- Data sources monitored: adverse event reports, published literature, international safety signals, MFDS database
- Methodology for data collection and analysis
- Frequency of surveillance activities
- Criteria for triggering corrective action (recall, FSCA, design change)
- Responsible persons for PMS activities
PMS report contentโ
Submitted to MFDS at MFDS-specified intervals:
- Summary of all adverse events reported during the period
- Analysis of complaint trends
- Signal assessment โ any new safety signals identified
- Actions taken or proposed
- Conclusion on the device's benefit-risk balance