New Delhi – The Union Ministry of Health and Family Welfare has proposed a series of significant amendments to the Medical Devices Rules (MDR), 2017, aimed at streamlining regulatory processes and enhancing global alignment. Key proposals introduced in April 2026 include allowing manufacturers of investigational medical devices already approved in the European Union to bypass mandatory clinical investigation results when seeking import or manufacturing permissions in India.
Key Regulatory Reforms Proposed
The draft notification introduces several structural changes to reduce administrative burdens while maintaining strict safety standards:
- Perpetual License Validity: A major reform proposes that manufacturing and import licenses, as well as registration certificates for notified bodies and testing labs, remain valid in perpetuity. This eliminates the need for periodic renewals, provided that mandatory retention fees are paid and compliance is maintained.
- Standardised Testing Fees: The ministry has proposed a fixed fee structure for testing and evaluation at government laboratories—such as ₹5,000 for implantation tests and ₹2,000 for sterility tests—with a planned 5% annual escalation.
- Quality Management for Class A Devices: For Class A (non-sterile and non-measuring) devices, manufacturers will now be required to submit a Quality Management System (QMS) as part of their self-certification documentation.
- Enhanced Labelling Requirements: Proposed changes to Rules 44 and 45 allow the use of a “Registration Number” (Reg. No.) on labels for Class A devices. Additionally, new rules may require manufacturers to print the license number of their sterilisation subcontractors on product labels, a move currently facing pushback from industry bodies like AiMeD.
New Compliance Documentation
The amendments introduce Form MD-44, a standardised format for reporting test or evaluation results from registered Medical Device Testing Laboratories (MDTLs) to declare device quality and conformity.
The government has invited stakeholders and the public to submit objections or suggestions regarding these draft rules within 30 days of the notification.
