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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
  • 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.