Medical devices are an important part of health care, yet they are an extraordinarily heterogeneous class of products. The Ministry of Health and Family Welfare has notified Medical Devices Rules (MDR), 2017 on 31.01.2017. The new rules have been framed in conformity with the Global Harmonisation Task Force (GHTF) framework. The new rules seek to remove regulatory bottlenecks to make in India, facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety. 

The new rules will help in developing a quality standardization framework in India at par with international standards. The implementation of these rules will ensure best quality, safety, and performance of medical devices. Salient features of MDR 2017 include Risk Based Classification, Provisions of Notified Bodies, Quality Management System in line with ISO 13485. All this will support entrepreneurship, market entry and economic growth that, in turn, would produce high-quality jobs. 

The knowledge on MDR 2017 provides guidance to assist manufacturers, traders/​distributors, importers, clinical establishments, healthcare professionals and public on nationally recognized medical devices standards and other regulatory requirements concerning medical devices in India. This workshop will be highly beneficial to professionals working in medical device industries and students planning to pursue their career in regulatory affairs, quality assurance and post-marketing surveillance of medical devices.