The Ministry of Health and Family Welfare has published a draft notification in the Official Gazette proposing amendments to the Medical Devices Rules, 2017, to simplify and expedite 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 the grant of manufacturing licences for medical devices across different risk categories. The initiative aims to enhance the ease of doing business, improve regulatory efficiency, and facilitate 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.
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 the grant of a 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.
The draft notification has been placed in the public domain for comments and suggestions from all stakeholders. The notification is available in the Official Gazette and on the website of the Central Drugs Standard Control Organisation (CDSCO). Stakeholders are invited to submit their comments and suggestions within the prescribed period.
