The Indian health ministry has proposed amendments to medical device rules to expedite licensing approvals for moderate to high-risk medical devices.
The draft notification aims to simplify and speed up the licensing process while maintaining quality, safety, and performance standards.
The proposed amendments seek to reduce licensing timelines for different risk categories, including Class B (low to moderate risk), Class C, and Class D (high-risk) devices.
For Class B devices, the timeline has been reduced from 140 days to 115 days, while Class C and D devices will see a reduction from 105 days to 90 days.
The draft amendments also introduce clear timelines for each stage of the licensing process, including scrutiny, audit, and issuance of licenses.
The initiative aims to bring greater transparency, predictability, and efficiency to the regulatory framework, benefiting both the medical device industry and patients.
