Medical Devices Rules, 2017: A Boost To The Indian Healthcare Industry

The Medical Devices Rules are a positive step towards making regulatory requirements more hassle-free and practical for manufacturers and importers alike

The Ministry of Health and Family Welfare notified the Medical Devices Rules, 2017 (“Medical Devices Rules”) on January 31, 2017 under the Drugs and Cosmetics Act, 1940 (“D&C Act”). However, the Medical Devices Rules have come into effect on January 1, 2018. These Rules seek to simplify the process of introducing new medical devices in the Indian healthcare market and simultaneously set standards for ensuring availability of high-quality medical devices for patient care and safety. The Rules have been framed to bring existing regulations in line with international practices and standards.

Medical Devices Rules: A forward step

Prior to the legislature penning down the Medical Devices Rules, medical devices were governed by the rules framed under the D&C Act. However, the definition of a ‘drug’ under the D&C Act included only 22 (twenty-two) categories of medical devices, leaving a majority of them unregulated. Having said that, in view of the aforesaid, it became increasingly important to have a separate regulation to govern medical devices inter alia for the following reasons:

To specifically regulate medical devices in India given the lacunae in the earlier laws;

To have a full-fledged legal framework to bring the Indian medical devices industry in line with international standards for medical devices prevailing in the global market;

To simplify manufacturing, sale, distribution, and import of medical devices to encourage foreign investors to set up their industries in India.