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

Voluntary vs. Directed Recalls

Voluntary Recall: Initiated by the manufacturer when safety issues are identified. Manufacturers must:

• Notify CDSCO immediately via SUGAM vigilance module
• Issue Field Safety Notice (FSN) to all affected customers
• Provide detailed recall plan to CDSCO
• Continue regular progress reports during recall execution

Directed Recall (CDSCO-Initiated): Initiated by CDSCO when post-market surveillance data indicates a safety issue. Manufacturers must:

• Comply with CDSCO recall direction within specified timeframes
• Follow CDSCO-defined recall strategy and communication requirements
• Submit daily/weekly progress reports as directed
• Implement recall at own expense

Both types require Field Safety Notice issuance, record-keeping of recall execution, and documentation of returned/destroyed device units.