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  • akshayakirithy replied to the topic Design Controls in the other countries in the forum Introduction to Design Controls 7 years, 9 months ago

    I see that there is brief discussion regarding the Medical Device regulation in India. There is no clinical trials or local testing of device if it is approved by other country market. I hope that this will be changed in near future. Being a most developing country in medical technology Medical device regulatory will be properly executed soon. But still there are few steps to get approved in India if the device is manufactured in India.
    Appoint a local agent in India to be the applicant and license holder
    Prepare Device Master File (DMF)
    Prepare Plant Master File (PMF)
    Prepare application Form w/supporting documents
    Submit above documents to DCGI with fees
    DCGI reviews and sends back an inquiry letter
    Applicant responds and addresses inquiries made by the DCGI
    DCGI may request technical presentation
    Approval