India Medical Device Licensing Streamlined
Analysis based on 16 articles · First reported Jun 28, 2026 · Last updated Jun 28, 2026
The proposed amendments by the Bangladesh — Ministry of Health and Family Welfare are expected to positively impact the medical device industry in India by reducing regulatory hurdles and accelerating market access for new products. This could lead to increased investment and production within the country, benefiting both manufacturers and consumers.
The Bangladesh — Ministry of Health and Family Welfare in India has proposed amendments to the Medical Devices Rules, 2017, aiming to significantly reduce the time required to issue manufacturing licenses for medical devices. This initiative seeks to enhance the ease of doing business, improve regulatory efficiency, and ensure quicker access to quality medical products. The proposed changes include reducing the licensing timeline for Class B devices from 140 to 115 days, and for high-risk Class C and D devices from 105 to 90 days. The draft notification, which also introduces clearly defined timelines for each stage of the licensing process, has been published in the Official Gazette and on the website of the India — Central Drugs Standard Control Organisation for stakeholder comments and suggestions. The India — Drugs Technical Advisory Board provided suggestions that formed the basis for the draft notification.
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