BioSpectrum India Magazine November issue BioSpectrum India Magazine - Page 23

www.biospectrumindia.com | November 2017 | COVERStory BioSpectrum Medical Devices Rules, 2017 opens up ENORMOUS OPPORTUNITIES The new Medical Devices Rules, 2017 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 rules will also regulate a much larger set of medical devices under a framework customized for medical devices. The stakeholders are hoping that the system will be industry friendly and will indeed create an ecosystem that will enable to boost medical technology innovation and manufacturing in the country. O n January 31, 2017 the Ministry of Health and Family Welfare has notified Medical Devices Rules, 2017. The new Rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices. The rules will come in to force with effect from January 1, 2018. 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. 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 23