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APPROVAL PROCESS AND REGISTRATION PROCESS OF MEDICAL DEVICES IN US, CANADA AND INDIA

N.Swetha*,D.Nagarjuna Reddy, M.V.Nagabhushanam, B.Brahmaiah, G.Ramakrishna

A medical device is any device intended to be used for medical purpose. Thus what differentiates a medical device from an everyday device is its intended use. In the United States, Medical devices are regulated by the FDACenter for Devices and Radiological Health (CDRH). Health Canada, under the authority of the Food and Drugs Act, regulates the sale of drugs and medical devices in Canada. The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory body for pharmaceuticals and medical devices. The Drug Controller General of India (DCGI) is the key official within the CDSCO. The approval and registration process and the recent market growth of medical devices is prepared and compared between US (FDA), CANADA (HEALTH CANADA) and INDIA (CDSCO).so my discussion is about approval and registration process of medical devices in US, CANADA AND INDIA. Keywords: Medical device approval process, regulatory requirements, registration process, market growth.

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