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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

PMS Plan Requirements

A comprehensive PMS plan must include:

  • Device identification and market distribution details
  • Complaint handling and investigation procedures
  • Methods for data collection (complaints, adverse events, sales data)
  • Analysis and trending procedures
  • CAPA (Corrective and Preventive Action) processes
  • FSCA procedures and approval workflow
  • Reporting timelines and escalation criteria
  • Post-market surveillance report frequency and content
  • Record retention and confidentiality measures

PMS plans must be maintained and updated regularly, with evidence of implementation available for regulatory inspection.

PMS Plan Approval: The PMS plan must be submitted to CDSCO as part of the device approval application or as a post-approval requirement specified in the approval letter. Any significant modifications to the PMS plan must be notified to CDSCO for approval before implementation. PMS plans for higher-risk devices (Class C and D) must be more detailed and may require enhanced post-market surveillance activities.