Govt plans self-certification for over 1,000 low-risk med devices

India plans to exempt lowrisk medical devices from cumbersome licensing processes and replace it with a system of self-certified online registration, according to two government officials and documents reviewed by Mint.

- Priyanka Sharma

Wheelchairs, stethoscopes are among such devices.

As part of a plan to ease approvals and support the government's push for indigenous manufacture of medical devices, sector regulator Drugs Controller General of India (DCGI) has finalized a list of 1,065 low-risk medical devices such as acoustic stethoscopes, wheelchairs, and alcohol swabs that will be exempt from licensing requirements.