The Ministry of Health and Family Welfare on Thursday notified Medical Devices Rules, 2017, which are in conformity with Global Harmonisation Task Force (GHTF) framework. While presenting the budget 2017-18 on February 1, 2017, Finance Minister Arun Jaitley had informed that the government was in process of formulating new rules for regulating medical devices.
Only 15 categories of medical devices are, at present, regulated as drugs and to that extent, the current regulatory practices in India were not fully geared to meet the requirements of medical devices sector in the country. The new rules seek to remove regulatory bottlenecks to Make