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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: (1) Field Safety Notice (FSN) issuance to all affected parties; (2) complete record-keeping of recall execution including dates, quantities, and distribution channels; (3) documentation of returned, destroyed, or reworked device units; and (4) submission of a final recall completion report to CDSCO within 90 days of recall closure.