India plans to exempt low-risk medical devices, supplies from licensing process

New Delhi: India plans to exempt low-risk 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 .

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.

This mandatory registration will ensure regulatory oversight by providing the regulator a complete database of all low-risk devices in the country. Also Read | India to ban promotion of medical devices and companie