This project examines the current regulatory landscape of medical devices in India by reviewing current medical device regulations and identifying any gaps or weaknesses. The ultimate goal of this project is to have a set of recommendations to ensure that medical devices are reliable and safe for use, ultimately improving patient outcomes and confidence in the healthcare system. We invite stakeholders, including healthcare professionals, industry representatives, and government agencies, to develop recommendations as part of this project.
Regulation of medical devices in India In India, the regulation of medical devices is governed by the Drugs and Cosmetics Act, 1940 and the rules framed thereunder. Medical devices are classified as drugs under the Drugs and Cosmetics Act, 1940 and are regulated as such. As per the Drugs and Cosmetics Act, 1940, a medical device is defined as any instrument, apparatus, appliance, implant, materia… more