Today, millions of patients depend on medical device-based treatment for the management and diagnosis of diseases. The quality and safety of the device depend upon the regulatory guidelines. Therefore, a law containing adequate guidelines of rules and regulations is required for monitoring the entry of such devices into the use of public health. The regulations define requirements for medical device design, development, and manufacture/import to ensure that products reaching the market are safe and effective. In India, the regulatory body CDSCO is governing for regulation of the medical devices, which, with time, amendments introduced in the medical device rules in 2017 will be adhered to by the manufacturer/importer before product entry to the market. In, Europe union the regulatory body European Medicines Agency and national bodies, require compliance with the medical device regulation 2017/745 will be adhered to by the manufacturer/importer before product entry to the market. The purpose of this review article is to present an overview process of the regulatory requirement in India and Europe.
CDSCO, IMDR, MDR 2017/45, EMA, NB, MF, NSWS