MEDICAL DEVICE REGULATION IN INDIA

Medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO) in India whose objective is to safeguard and enhance the public health by assuring the safety, efficacy, and quality of medical devices. Medical devices are regulated under the Drugs and Cosmetics Act 1940.

MEDICAL DEVICE REGISTRATION AND APPROVAL IN INDIA

Medical devices are classified into 2 categories namely: Notified Medical Devices and Non-notified Medical Devices.

The list of Notified Medical Devices is listed in CDSCO requirement and registration is required for these devices.