India Registration
Medical
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
