The Ministry of Health and Family Welfare (MoHFW), on June 23, 2026, published the draft Medical Devices (…Amendment) Rules, 2026 proposing amendments to the Medical Devices Rules, 2017. The draft rules seek to streamline the licensing process for medical devices by revising timelines for application scrutiny, audits, inspections, and grant of licences. Stakeholder comments and objections have been invited within 30 days from the date the draft rules are made available to the public in the Gazette.
The draft amendments propose that the State Licensing Authority complete scrutiny of Class B medical device manufacturing licence applications within 30 days of online submission before assigning them to a Notified Body. It further mandates that the manufacturing site conform to the prescribed Quality Management System (QMS) requirements under the Fifth Schedule, with compliance to be verified through an audit by a Notified Body before licence grant. The draft also requires the Notified Body to complete site audits within 30 days of assignment, verify rectification of QMS non-conformities within 20 days of receiving the manufacturer's compliance report, and submit its final audit report with recommendations to the State Licensing Authority within 15 days after completion of the audit.
Additionally, the draft rules propose reducing several regulatory timelines to expedite approvals. The time limit under Rule 21(4) is proposed to be reduced from 45 days to 30 days, while the period under Rule 23(1) is proposed to be reduced from 60 days to 55 days. A new provision under Rule 23(3) requires compliance verification of QMS non-conformities identified during inspections to be completed within 15 days of receipt of the manufacturer's compliance report. Further, the timeline under Rule 25(1) is proposed to be reduced from 45 days to 20 days, thereby accelerating the licensing process for medical device manufacturers.
The proposed amendments are intended to improve regulatory efficiency, strengthen quality assurance through time-bound audits and inspections, and facilitate faster processing of manufacturing licences while maintaining compliance with prescribed quality standards.
[Notification No. G.S.R. 515(E)]
