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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

Field Safety Corrective Action (FSCA) Requirements

FSCA actions must:

  • Be documented with clear rationale linking findings to corrective measures
  • Be submitted to CDSCO for review and approval before implementation
  • Include communication plans for healthcare facilities, practitioners, and patients as applicable
  • Be implemented within CDSCO-approved timelines
  • Include verification of effectiveness across the distributed device population
  • Be tracked and reported in Post-Market Surveillance Reports

Common FSCA measures include product recalls, product modifications, restrictions on use, or labeling changes.