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India Cuts Medical Device Approval Times
28 Jun
Summary
- New rules aim to speed up manufacturing licenses for medical devices.
- Timelines for Class B devices reduced from 140 to 115 days.
- Class C and D device license approval reduced from 105 to 90 days.
The Union Ministry of Health and Family Welfare has proposed significant amendments to the Medical Devices Rules, 2017, aiming to drastically reduce the time taken to grant manufacturing licenses for medical devices. Published on June 28, 2026, these draft rules simplify and expedite the licensing process while maintaining stringent quality and safety standards.
The proposed changes specifically target the rationalization of timelines across different risk categories of medical devices, classified from A (lowest risk) to D (highest risk). For Class B devices, such as blood pressure monitors and hypodermic needles, the approval period is set to decrease from 140 days to 115 days.
Furthermore, high-risk devices including cardiac stents and implants, categorized as Class C and D, will experience a reduction in their manufacturing license grant period from 105 days to 90 days. This initiative is designed to boost the ease of doing business and improve regulatory efficiency.
The draft amendments also introduce explicitly defined timelines for each sequential step in the licensing procedure. This includes application scrutiny, audits by notified bodies, compliance verification, and the final issuance of licenses, fostering greater transparency and predictability.
