Page 62 - The Indian Digital Edition September-October 2020

INDIAN OPTICAL

SECTOR RATTLED

BY UNFORESEEN

PROPOSALS

edical devices are essential apply to all medical devices. Prior to Devices (Amendment) Rules,
for safe and effective the amendment, only 37 categories manufacturers or importers will be
Mprevention, diagnosis, of medical devices were regulated or required to compulsorily register
treatment and rehabilitation of were notified to be regulated in the their medical devices, including so
illness and diseases. The products near future. far unregulated medical devices, for
that are classified as medical devices a license with the Drugs Controller
are any instrument, apparatus, In pursuance of the new General of India (DCGI) before 1
implement, machine, appliance, regulations, the Government of October 2021. However, those
implant, reagent for vitro use, India gazetted two notifications on medical devices which are already
material or other article, whether 1 April 2020 – a new definition of regulated or have been notified to
used alone or in combination, medical devices and The Medical be regulated are exempted from
including software or an accessory. Devices (Amendment) Rules, 2020 – registration.
By definition, this covers such that brings all medical devices and The DCGI has started accepting
products used in all fields including medical equipment sold in India applications for registration through
the optical sector but so far did under the existing quality and safety a dedicated online portal called the
not include frames, sunglasses and regulatory framework by declaring “Online System for Medical Devices”
contact lenses. them as “drugs” under the Drugs and
Cosmetics Act (DCA) and Medical from 1 April 2020, or from a later
In an unexpected development, Devices Rules (MDR). This means that date by when the online portal is
a new definition for all medical all medical devices in the country ready to accept applications. The
devices has been proposed, to are now covered by the drug control registration will be done after the
be regulated as “drugs” under the regulation that was put in place submission of all information and
Medical Devices (Amendment) Rules, earlier to make drugs affordable and documents on the online portal,
2020. The Indian law that regulates accessible to all. that is without any examination of
quality and safety of medical devices the information and documents
is sought to be amended, to now Under the newly notified Medical submitted by the applicant to the

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