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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

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.