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

Communication Requirements: Manufacturers must notify all customers (hospitals, distributors, retailers, healthcare practitioners) of recalls via direct communication (email, letter, phone) within 24 hours of CDSCO approval or discovery of a safety issue. Notification must include: device identification (name, batch/lot numbers, serial numbers), reason for recall/action, risk assessment, recommended actions for end-users, and contact information for further details. A public announcement via CDSCO website and professional medical organizations may be required for serious safety issues. Documentation of all communication attempts and confirmation of receipt must be maintained and submitted to CDSCO.