The Union health ministry has suggested changes to the Medical Devices Rules, 2017, to streamline and speed up the licensing process for making medical devices, while maintaining standards for quality, safety and performance, according to a statement issued on Sunday. The move seeks to improve ease of doing business, enhance regulatory efficiency, and ensure quicker access to reliable medical devices nationwide. It also targets shorter statutory processing periods for manufacturing licences in different risk categories. India’s medical device industry, valued at $13 billion by the India Brand Equity Foundation, has called for such reforms to cut delays and support local production. Devices fall into four risk classes—A, B, C and D—with D covering the highest-risk items. The changes would shorten approval times without lowering quality standards. For Class B devices, such as blood pressure monitors, hypodermic needles and pulse oximeters, the licence timeline would drop from 140 days to 115 days. For higher-risk Class C and D products, including cardiac stents and orthopaedic implants, it would fall from 105 days to 90 days. The draft sets clear deadlines for each step, including application review, audits, compliance checks and final licence issuance. Officials say this will add transparency and predictability to the system, helping manufacturers and patients alike. The draft notification has been released for public feedback, available in the Official Gazette and on the CDSCO website, with comments due within 30 days.
