The Union government proposes amendments to India’s Medical Devices Rules, 2017, aimed at shortening licensing timelines for medical device manufacturing. According to multiple reports, the health ministry is working on draft changes that define specific timeframes for different stages of the licensing process, with the goal of improving regulatory efficiency and supporting easier business operations. The proposals focus in particular on higher-risk categories of devices. Business Standard reports that manufacturing licence timelines are intended to be reduced for Class B, Class C and Class D medical devices, while Business Line and Mint frame the initiative more broadly as a measure to ensure timely access to quality medical devices. Mint adds that the amendments lay out timelines for each step of the licensing workflow, rather than leaving the process duration undefined. The government is therefore moving to make the regulatory approval process more time-bound, with the stated objectives of streamlining permissions and helping manufacturers bring medical devices to market faster.
Centre proposes faster licensing timelines for medical device manufacturing
The Union government proposes amendments to India’s Medical Devices Rules, 2017, aimed at shortening licensing timelines for medical device manufacturing. According to multiple reports, the health min...
- The health ministry proposes amendments to the Medical Devices Rules, 2017.
- The draft changes introduce defined timelines for stages of the medical device licensing process.
- The proposal aims to reduce manufacturing licence timelines for higher-risk devices.
- The focus is on Class B, Class C and Class D medical devices.
- Reported goals include improving regulatory efficiency and easing doing business while enabling timely access to quality medical devices.
The health ministry's proposed amendments to the Medical Devices Rules, 2017, introduce defined timelines for each stage of the licensing process.
1 month agoDraft amendments to the Medical Device Rules seek to reduce manufacturing licence timelines for Class B, C and D devices to improve regulatory efficiency and ease of doing business
1 month agoThe initiative aims to enhance business ease, improve regulatory efficiency, and ensure timely access to quality medical devices
1 month ago
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