The Union Ministry of Health has proposed sweeping amendments to the Medical Devices Rules, 2017, to significantly compress timelines for licensing and auditing of medical devices in India.The move aims to accelerate the availability of medical devices in the country while maintaining quality standards. Stakeholder comments have been invited over 30 days.The rules propose six amendments to the rules, each targeting a specific stage of the licensing and quality audit process.Class B device application scrutiny has been reduced to 30 days. Class B devices include low-to-moderate risk, non-invasive or minimally invasive equipment like hypodermic needles, surgical gloves and BP monitors. Under the proposed amendment to Rule 20, Sub-rule (5), the State Licensing Authority will be required to complete the scrutiny of applications for Class B devices and assign them to notified bodies within 30 days of the date of submission. An additional sub-clause — 5(A) — has been inserted to make explicit that the manufacturing site of the applicant must conform to Quality Management System (QMS) requirements and this conformity must be verified through an audit by a notified body before any licence is granted. A 30-day deadline has been introduced for the audit of the manufacturing site.A new sub-clause — (i)(a) — has been inserted to address quality non-conformance found during the audit. In such cases, compliance verification must be completed within 20 days of receipt of the compliance report from the manufacturer.Another amendment to Rule 21, Sub-rule (4), which deals with applications for manufacturing Class C or Class D devices, reduces the relevant procedural timeline for scrutiny of papers from 45 days to 30 days.Class C and D medical devices are high-risk, moderate-to-life-supporting equipment regulated by the apex drug body. These devices are typically invasive, used for administering life-sustaining substances, or involve energy transfer to the body. Examples include dialysis machines, pacemakers, coronary stents, etc.Another amendment has been made to Rule 23, Sub-rule (1), which deals with the grant of licence to manufacture for sale or distribution in respect of Class C or D medical device. The current provision says the manufacturing site shall be inspected within 60 days from the date of application.This 60-day period has been cut to 55 days. The deadline for the grant of licence or loan licence to manufacture for sale or for distribution with respect to Class C and D devices post the receipt of the inspection team’s report (Rule 25 Sub-rule [1]) is proposed to be reduced from 45 to 20 days — in the steepest single compression of deadline in the draft amendments.The Medical Devices Rules were published on January 31, 2017, for a comprehensive regulatory framework for the manufacture, import, sale and distribution of medical devices in India. These covered everything from surgical instruments and diagnostic equipment to implants and in-vitro diagnostic kits. The amendments proposed directly address the time taken at various stages of the licensing chain — from initial application scrutiny and assignment to notified bodies through site audit and compliance verification to the final steps of the licensing process.The sharp reduction in timelines, particularly the halving of the Rule 25 deadline from 45 to 20 days, seeks to make India’s medical device regulatory process more competitive in the global context, where manufacturers and investors often cite long approval timelines as a deterrent to bringing new devices to the Indian market. Parallel insertion of quality conformance requirements at each stage, including the mandatory QMS audit and the structured compliance verification windows, indicates that the speed improvements are designed to accompany, not replace, quality rigour.