NEW DELHI — In a major move to boost regulatory efficiency and enhance the ease of doing business, the Union Ministry of Health and Family Welfare has issued a draft notification to amend the Medical Devices Rules, 2017.
Published in the Official Gazette, the proposed amendments aim to significantly shorten the statutory timelines for granting medical device manufacturing licenses, ensuring faster market access while maintaining strict quality, safety, and performance standards.
Streamlining Risk-Based Licensing Timelines
Under the existing Medical Devices Rules, 2017, devices are divided into four risk categories: Class A (lowest risk) through Class D (highest risk). The new draft specifically targets and compresses the waiting periods for mid-to-high-risk medical equipment.
Key Timeline Reductions:
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Class B Devices (Low-to-moderate risk; e.g., blood pressure monitors, hypodermic needles, pulse oximeters): The regulatory timeline to grant a manufacturing license is proposed to drop from 140 days down to 115 days.
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Class C & D Devices (Moderate-high to high risk; e.g., cardiac stents, hip/knee replacements, orthopedic implants): The approval timeline is slated to shrink from 105 days down to 90 days.
Structural Transparency and Stakeholder Feedback
Beyond cutting total days, the draft rules introduce explicit, structured timelines for every intermediate phase of the regulatory pipeline. This includes hard targets for application scrutiny, audits by notified bodies, compliance verifications, and final license distribution to ensure predictability for manufacturers.
The draft notification has been hosted on the Central Drugs Standard Control Organisation (CDSCO) portal and the official e-Gazette repository, opening a public consultation window for industry stakeholders and patients to submit feedback before final implementation.
