The Ministry of Health and Family Welfare has notified Medical Devices Rules, 2017 on 31.01.2017. The new Rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices. 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 in India, facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety.

Medical devices will, under the new Rules, be classified as per GHTF practice, based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements that have been specified in the Rules and are based on best international practices.

Separate provisions for regulation of Clinical Investigation (clinical trials) of investigational medical devices (i.e. new devices) have also been made at par with international practices and, like clinical trials, these will be regulated by CDSCO. Conduct of clinical investigations will, while following the international practices, be conducted in a manner that ensures realization of the twin objectives of patient safety and welfare and discovery of new medical devices. Medical management and compensation will be provided to the subject of clinical investigation in accordance with the predefined and objective criteria laid down by the Government.

The Rules will provide a conducive environment for fostering India specific innovation and improving accessibility and affordability of medical devices across the globe by leveraging comparative cost advantage of manufacturing in India. The objective, transparent and predictable regulatory framework will boost the confidence of investors and, as a consequence, the quality and range of products and services will improve and business burdens will be reduced. The new Rules will help in developing a quality standardization framework in India at par with international standards. The implementation of these Rules will provide the assurance of the best quality, safety and performance of medical devices. These Rules coupled with other measures, taken by the Government in the recent past, are expected to sharpen the competitive edge and provide incentives to firms to become more efficient, innovative, and competitive. All this will support entrepreneurship, market entry and economic growth that, in turn, would produce high-paying, high-quality jobs.

Courtesy: PIB

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