CDSCO Medical Device License Audit: Compliance Checklist for Manufacturers

CDSCO medical device license audit is not just a document review. It is the checkpoint that determines whether the medical device manufacturer is actually operating in conformity with the Medical Devices Rules, 2017, with the audit route also depending on the class of device and licensing authority. In Class A and B devices, the audit or inspection steps of the notified body and the State licensing authority take centre stage, as Class C and D devices pass through Central licensing authority inspection of manufacturing buildings and licensing procedures.