India proposes faster licensing for medical devices

India's Union Ministry of Health and Family Welfare is moving to streamline the medical device approval process. The ministry has proposed amendments to the Medical Devices Rules, 2017, aiming to significantly shorten the licensing timelines for moderate to high-risk medical devices. This initiative seeks to enhance the ease of doing business and improve regulatory efficiency, ensuring quicker access to quality medical devices for the public.

The proposed changes will reduce the time taken to grant manufacturing licenses. For Class B devices, such as blood pressure monitors and pulse oximeters, the timeline is set to decrease from 140 days to 115 days. High-risk devices, including cardiac stents and implants (Class C and D), will see their licensing period reduced from 105 days to 90 days. Class A devices, like medical thermometers, will remain unchanged.

These amendments are based on suggestions from the Drugs and Technical Advisory Board (DTAB) and aim to balance expedited approvals with continued adherence to stringent quality, safety, and performance requirements. The draft notification also introduces clearly defined timelines for each stage of the licensing process, including application scrutiny and audits by notified bodies. The applicant's manufacturing site must meet quality management system requirements, verified through an audit before a license is granted.

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The ministry of health and family welfare has published a draft notification in the Official Gazette proposing amendments to the Medical Devices Rules, 2017, with the objective of simplifying and expediting the licensing process for medical devices while ensuring continued compliance with quality, safety and performance requirements.