Cdsco Inspections

CDSCO conducts GMP inspections for Class C and D device manufacturers, while State Licensing Authorities (SLAs) conduct inspections for Class A and B manufacturers. Inspections are conducted both at the licence grant stage and during periodic surveillance throughout the licence validity period.

The Production Linked Incentive (PLI) scheme for medical devices offers financial incentives to eligible Indian manufacturers. See DPIIT PLI scheme for eligibility and application details.

Official source: Medical Devices Rules 2017; CDSCO; DPIIT PLI

GMP inspections assess compliance against Schedule 5 requirements including: management responsibility, design controls, document controls, purchasing, production process controls, acceptance criteria, complaint handling, and CAPA. Initial licence inspections are unannounced or with short notice. Inspectors issue observations and non-conformances. Critical non-conformances must be resolved before licence grant. Major non-conformances require documented corrective action within 30 days. Minor observations should be closed within 90 days. Surveillance inspections typically occur every 2 years, with frequency increased for manufacturers with history of non-compliance.