Skip to main content

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