Device Registration Certificate in Form 41 (For Foreign Manufacturer)
· Determine your device fits or not into the list of notified Medical Devices regulated under Drugs and Cosmetics Act, 1940; and Rules, 1945.
· Coordinate the device registration and approval process with Indian Medical Device Regulators (DCG(I)/CDSCO)
· Preparation of all necessary documents for the product registration application including Forms 40.
· Suggesting appointing an Indian Agent as your official representative.
· Submission of Site Master File and Device Master File as needed.
· Coordinate with the DCG(I)/CDSCO to address follow up questions and monitor progress