The Union Ministry of Health and Family Welfare has proposed sweeping amendments to the Medical Devices Rules, 2017, that would significantly compress timelines for licensing and audit of medical devices— reducing key deadlines by up to more than half.The move aims to accelerate the availability of medical devices in the country while maintaining quality standards.The draft amendment rules, published in the Gazette of India this week, have been issued after consultation with the Drugs Technical Advisory Board and objections and suggestions have been invited from stakeholders within 30 days of publication.Amendments proposedThe draft rules propose six substantive amendments to the Medical Devices Rules, 2017, each targeting a specific stage of the licensing and quality audit process.Class B device application scrutiny has been reduced to 30 days. Under the proposed amendment to Rule 20, Sub-rule (5), the State Licensing Authority (SLA) will be required to complete the scrutiny of applications for Class B medical devices and assign them to Notified Bodies within 30 days of the date of online submission of the application. The current rules do not specify this compressed deadline with the same precision. A provision has been included to address deficiencies: where the SLA points out rectifiable deficiencies within the stipulated period, the 30-day clock will restart from the date those deficiencies are removed by the applicant.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 as specified under the Fifth Schedule and all applicable standards under the rules, and that this conformity must be verified through an audit by a Notified Body before any licence is granted. This codifies an existing practice but gives it the force of a specific statutory requirement.A 30 day deadline has been introduced for site audit by a notified body to carry out the audit of the manufacturing site.The audit report must then be submitted to the State Licensing Authority.A new sub-clause — (i)(a) — has been inserted to address quality non-conformances found during the Notified Body audit. Where such non-conformances are observed, compliance verification must be completed within 20 days of receipt of the compliance report from the manufacturer.This provision creates a firm deadline for quality follow-up, closing a gap in the existing framework.Under the amended Clause (ii) of the same sub-rule, the Notified Body must furnish its final report along with recommendations to the State Licensing Authority within 15 days of completion of the audit.This is a tighter and more specific requirement than the existing provision.Class B medical devices are low-to-moderate risk, non-invasive or minimally invasive, examples being hypodermic needles, surgical gloves, BP monitors.Another amendment to Rule 21, Sub-rule (4) which deals with application for manufacturing Class C or Class D devices, replaces the word “forty-five” with “thirty” reducing 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.The change proposes a straight reduction of one-third in the applicable period under this sub-rule.One more amendment has been made to Rule 23 Sub-rule (1) which deals with 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 a period of sixty days from the date of application.This 60 day period has been cut to 55 Days. Deadline for 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. This represents the steepest single compression of a deadline in the entire draft amendment.Background and ContextThe Medical Devices Rules, 2017 were originally published on January 31, 2017, and established the comprehensive regulatory framework for the manufacture, import, sale and distribution of medical devices in India — covering everything from surgical instruments and diagnostic equipment to implants and in-vitro diagnostic kits. India’s medical devices sector has been a focus of regulatory reform in recent years as the government seeks to position the country both as a destination for medical device manufacturing and as a market where patients can access safe, quality-assured devices without undue delay caused by regulatory bottlenecks. The amendments now 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 — signals a clear policy intent 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.At the same time, the insertion of explicit quality conformance requirements at each stage — including the mandatory QMS audit under the new Sub-clause 5(A) and the structured compliance verification windows under the new Rule 23(3) — indicates that the speed improvements are designed to accompany, not replace, quality rigour.Stakeholder participationThe Central Government has invited objections and suggestions from all persons likely to be affected by the proposed rules — including medical device manufacturers, importers, Notified Bodies, State Licensing Authorities, healthcare providers, industry associations and patient groups. The 30-day window for submissions runs from the date the Gazette copies are made available to the public.The draft rules, once finalised after consideration of public input, will come into force on the date of their final publication in the Official Gazette, unless otherwise specified.