BioSpectrum India Magazine November issue BioSpectrum India Magazine | Page 23

www.biospectrumindia.com
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November 2017
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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
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