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    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