Recalls & Field Safety Actions

Medical device recalls in India may be voluntary (initiated by the manufacturer) or CDSCO-directed. All recalls require a Field Safety Notice (FSN) to customers and coordination with CDSCO via the SUGAM vigilance module.

Official source: Medical Devices Rules 2017, Schedule 7; CDSCO

Field Safety Notice (FSN) Content Requirements: The FSN is the formal written notification to customers and must include: unique FSN reference number and date, affected device identification (name, strength/size, batch/lot/serial numbers, country of origin), clear description of the safety issue or defect, risk classification (Class A, B, or C based on severity), recommended corrective action for healthcare facilities and patients, expected timeline for resolution or replacement, return/destruction instructions, and contact information for questions. The FSN must be approved by CDSCO before distribution to customers. Multiple FSNs may be issued for a single recall if information is updated. All FSN templates and distribution records must be retained for regulatory inspection.