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 while maintaining quality standards.
Draft Amendments Published for Public Comment
The draft amendments, published in the Gazette of India this week, have been issued after consultation with the Drugs Technical Advisory Board. Stakeholders have been given 30 days to submit objections and suggestions. The proposed rules target six specific stages of the licensing and quality audit process.
Class B Device Application Scrutiny Reduced to 30 Days
Under the proposed amendment to Rule 20, Sub-rule (5), the State Licensing Authority (SLA) will be required to complete scrutiny of applications for Class B medical devices and assign them to Notified Bodies within 30 days of online submission. A provision addresses deficiencies: if the SLA points out rectifiable issues within the stipulated period, the 30-day clock restarts from the date those deficiencies are removed.
An additional sub-clause—5(A)—has been inserted to explicitly require that the manufacturing site conform to Quality Management System (QMS) requirements as specified under the Fifth Schedule and all applicable standards, verified through an audit by a Notified Body before any licence is granted. This codifies existing practice into a specific statutory requirement.
A 30-day deadline has been introduced for the Notified Body to carry out the site audit, with the audit report then submitted to the State Licensing Authority. A new sub-clause—(i)(a)—addresses quality non-conformances found during the audit: compliance verification must be completed within 20 days of receipt of the compliance report from the manufacturer. Under the amended Clause (ii), the Notified Body must furnish its final report with recommendations to the SLA within 15 days of audit completion.
Class B medical devices are low-to-moderate risk, non-invasive or minimally invasive, such as hypodermic needles, surgical gloves, and blood pressure monitors.
Class C and D Devices: Timeline Reductions
Another amendment to Rule 21, Sub-rule (4)—dealing with applications for manufacturing Class C or Class D devices—replaces the word “forty-five” with “thirty,” reducing the procedural timeline for scrutiny of papers from 45 days to 30 days. Class C and D devices are high-risk, moderate-to-life-supporting equipment regulated by the apex drug body, including dialysis machines, pacemakers, and coronary stents. This change proposes a one-third reduction in the applicable period.
Under Rule 23, Sub-rule (1)—which deals with grant of licence to manufacture for sale or distribution for Class C or D devices—the current 60-day period for site inspection has been cut to 55 days. The deadline for grant of licence or loan licence after receipt of the inspection team’s report (Rule 25, Sub-rule (1)) is proposed to be reduced from 45 to 20 days, representing the steepest single compression of a deadline in the entire draft amendment.
Background and Context
The Medical Devices Rules, 2017 were originally published on January 31, 2017, establishing a comprehensive regulatory framework for manufacture, import, sale, and distribution of medical devices in India—covering surgical instruments, diagnostic equipment, implants, and in-vitro diagnostic kits. India’s medical devices sector has been a focus of regulatory reform as the government seeks to position the country as a manufacturing destination and ensure patients can access safe, quality-assured devices without undue regulatory delay.
The sharp reductions in timelines—particularly the halving of the Rule 25 deadline from 45 to 20 days—signal a clear policy intent to make India’s medical device regulatory process more competitive globally, where long approval timelines have been cited as a deterrent. At the same time, the insertion of explicit quality conformance requirements at each stage indicates that speed improvements are designed to accompany, not replace, quality rigour.
According to the ministry, the draft amendments were issued after consultation with the Drugs Technical Advisory Board. Stakeholders—including manufacturers, importers, Notified Bodies, State Licensing Authorities, healthcare providers, industry associations, and patient groups—have 30 days to submit objections and suggestions. The final rules will come into force on the date of their final publication in the Official Gazette, unless otherwise specified.
