Medical Devices Rule 2017

Ministry of Health and Family Welfare (MOH&FW) notified the Medical Devices Rules 2017 on 31.01.2017 under the provisions of the Drugs and Cosmetics Act, 1940. The MDR 2017 are effective from 01.01.2018 to regulate the Clinical Investigation, Manufacture, Import, Sale and Distribution of the medical devices in the country. These rules are harmonised with the international regulatory practices and provide comprehensive legislation for the regulation of Medical Devices fostering Make in India as well.

To download a copy of the MDR 2017, please click HERE