Feb 17, 2020

India’s Central Drugs Standard Control Organization (CDSCO) has expanded the scope of products falling under medical device regulation in the country, and also established an expedited registration route for some devices.

CDSCO announced these changes via two final amendments to India’s Medical Device Rules, 2017; both amendments take effect April 1, 2020.

Expanded definition of “medical device”

First, CDSCO’s expansion of the definition of a medical device aligns more closely with that of the Global Harmonization Task Force (GHTF), effectively increasing the scope of products that will require registration as devices in order to be sold in India.

Expedited registration for newly notified devices

Second, CDSCO has added a new section to the Medical Device Rules, 2017, Chapter IIIA: Registration of Certain Medical Devices, which sets up a new registration route for qualifying manufacturers whereby required documentation and certifications may be uploaded for regulatory review via an online portal.

Emergo consultants note that medical devices currently notified under the Medical Device Rules, 2017 will not qualify for the expedited Chapter IIIA registration option, suggesting that the new route may be an option for products that will become notified in April under the associated amendment expanding the definition of a medical device in India. Devices brought to market under this expedited route will furthermore be exempt from other requirements of the Medical Device Rules, 2017.

Chapter IIIA registration will be voluntary for 18 months following the route’s implementation; whether devices that will become notified in April but rely on standard Indian registration pathways will fall wholly under other provisions of the Medical Device Rules, 2017 remains to be determined.

Learn more about Indian medical device regulations and CDSCO registration: