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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.

Emergency FSCA: In cases of imminent risk to public health, FSCA measures (e.g., urgent product recall or use restriction) may be implemented immediately with simultaneous notification to CDSCO. Formal approval must be obtained within 7 days for emergency actions. Non-emergency FSCA measures must obtain written CDSCO approval before implementation.