The Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules, 2017 to simplify and shorten the timelines for the grant of manufacturing licences for medical devices across different risk categories.

In a gazette notification, the Ministry said this initiative is also aimed at enhancing the ease of doing business, improving regulatory efficiency, and facilitating the timely availability of quality medical devices in the country.

Under the Medical Devices Rules, 2017, medical devices are classified into four risk-based categories—Class A, Class B, Class C and Class D—with Class D comprising highest-risk devices.

“The Rules prescribe statutory timelines for processing applications for manufacturing licences for each category. The proposed amendments seek to reduce these timelines, thereby enabling faster regulatory approvals, while maintaining the established standards of quality, safety and performance,” it said.

For Class B medical devices, which include low to moderate risk devices such as blood pressure monitors, hypodermic needles and pulse oximeters, the timeline for grant of manufacturing licence has been proposed to be reduced from 140 days to 115 days.

Similarly, for Class C and Class D medical devices, which include high-risk devices such as cardiac stents, hip and knee implants, and other orthopaedic implants, the timeline for grant of manufacturing licence has been proposed to be reduced from 105 days to 90 days.

The draft amendments also introduce clearly defined timelines for each stage of the licensing process, including scrutiny of applications, audit by notified bodies, verification of compliance and issuance of licences.

“This is expected to bring greater transparency, predictability and efficiency to the regulatory framework, benefiting both the medical device industry and patients through faster access to quality-assured medical devices,” it added.

The draft notification has been placed in the public domain for comments and suggestions from all stakeholders within 30 days of the publication.

Published on June 28, 2026