Health Ministry Proposes Amendments to Medical Devices Rules to Streamline Licensing Process

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.

The proposed amendments seek to rationalize the timelines for grant of manufacturing licences for medical devices across different risk categories. The initiative is 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 the 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.

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.
(UPDATED ON 28TH JUNE 2026)