Sla Audits

CDSCO (for Class C/D manufacturers) and State Licensing Authorities (for Class A/B manufacturers) conduct GMP inspections as part of the licence grant and surveillance process.

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

Add content explaining: SLA audit scope and frequency, audit procedures for Class A/B manufacturers, documentation requirements for audit readiness, non-conformance reporting and resolution, audit timelines, re-inspection procedures, and compliance verification processes specific to State Licensing Authorities.