Post-Market Surveillance
Manufacturers and IARs must maintain a Post-Market Surveillance (PMS) plan and submit a Post-Market Surveillance Report (PMSR) to CDSCO as required by MDR 2017.
The PMS plan should cover complaint handling, trending, CAPA, and field safety corrective action (FSCA) procedures.
Official source: Medical Devices Rules 2017; CDSCO
Post-Market Surveillance Report (PMSR) Submission
Manufacturers and IARs must submit PMSRs to CDSCO containing:
- Summary of complaints received and their classification
- Trend analysis of complaint data
- Details of CAPA and FSCA actions initiated
- Effectiveness of corrective actions implemented
- Any safety-related product modifications or labeling changes
- Regulatory actions or recalls in other countries (if applicable)
- Overall device safety assessment
Submission Frequency: As specified in approval conditions (typically annually for lower-risk devices, or as requested by CDSCO)
PMSRs must be supported by complete documentation and complaint records available for regulatory review.
Enhanced PMSR Requirements: For Class C and D devices, or devices with specific safety concerns identified during approval, PMSR may require: detailed adverse event narratives, comparative safety data against competitor products, patient outcome tracking data, healthcare professional feedback, and pharmacovigilance data (if applicable). CDSCO may request interim PMSRs at any time or increase submission frequency based on post-market safety signals.