The Ministry of Health and Family Welfare has recommended significant changes to the regulatory framework governing medical devices in India. These proposed amendments aim to simplify licensing procedures, strengthen compliance, and introduce perpetual validity for licences and registration certificates under the Medical Devices Rules, 2017.
Key Regulatory Changes Proposed
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Draft Gazette Notification Issued
Recently, the Government published a draft notification titled Medical Devices (Amendment) Rules, 2024 in the Gazette of India. The notification outlines a range of changes to the existing Medical Devices Rules, 2017, which regulate the registration and licensing of all medical devices, including in vitro diagnostic products.
It was issued under the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB). Stakeholders and affected parties can send their objections or suggestions within 30 days from the date the Gazette notification was released.
Simplifying Identification and Documentation
The proposal introduces streamlined provisions for product identification and documentation. For example:
- Amendments to rules 44 and 45 allow the use of registration numbers for Class A (Non-Sterile and Non-Measuring) devices in specific cases.
- A new sub-rule under Rule 85 mandates that holders of registration certificates must furnish test or evaluation data in the newly introduced Form MD-44.
These changes reduce redundancy and ensure clearer traceability across regulatory documents.
Perpetual Validity for Licences and Registrations
A major proposal, highlighted as per Medical Dialogues in the draft Gazette notification, is to grant perpetual validity to licences and registration certificates. Under the updated rules:
- Licences and registrations will remain valid indefinitely unless they are suspended, cancelled, or surrendered.
- To maintain validity, holders must pay retention fees as specified under the Medical Devices Rules, 2017.
This move marks a shift from the current system of time-bound renewals, eliminating repetitive renewal filings and lowering administrative burden for manufacturers and importers.
Other Technical Adjustments
In addition to changes on validity and documentation:
- The term “AND NOTIFIED BODY” will be removed from the heading of Chapter IX, which may refine regulatory oversight structures.
- Several updates clarify inspection and testing requirements in forms like MD-11 to align with the new compliance framework.
What Comes Next
Once the 30-day public consultation period ends, the Ministry will review all suggestions and objections before finalising the amendments. If adopted, these changes could decisively streamline the medical device regulatory process, support industry growth, and strengthen quality monitoring across India’s healthcare sector.