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
Complaint Handling Procedures
Manufacturers and Importers of Authorized Representatives (IARs) must establish documented procedures for:
- Receiving and logging all complaints within 2 working days of receipt (complaints received orally, in writing, or via digital channels must all be formally documented)
- Investigating complaints and documenting findings
- Classifying complaints by severity and device risk
- Trending complaint data to identify patterns
- Escalating serious adverse events to CDSCO via SUGAM within required timeframes
- Maintaining complaint records for the device's lifetime plus additional retention period
Complaints must be evaluated to determine if they indicate a potential safety issue or adverse event requiring regulatory notification.
Complaint Assessment Timelines: Manufacturers must assess the safety significance of complaints within 30 days of receipt. Complaints indicating a serious adverse event or device malfunction must be escalated to CDSCO via SUGAM immediately, and in any case not later than 15 calendar days from receipt. Severity classification should distinguish between minor (no patient harm), serious (potential for patient harm), and critical (patient death or serious injury).