NEW DELHI — The Union Ministry of Health and Family Welfare has introduced key regulatory amendments to the Medical Devices Rules, 2017. The proposed changes aim to simplify compliance, standardize testing costs, and accelerate market entry for innovative medical technologies.
The reforms focus on three core areas: easing licensing for outsourced sterilization, introducing a uniform testing fee structure, and expanding recognized international jurisdictions to include the European Union for clinical trial waivers.
Key Policy Amendments & Regulatory Reforms
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Outsourced Sterilization Simplification (Rule 44): Manufacturers using third-party sterilization facilities will no longer need to obtain a separate loan license under Rule 25, provided the service provider holds a valid license under the Medical Devices Rules, 2017.
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Standardized Testing Fee Schedule (Ninth Schedule): Introduces a newly inserted Ninth Schedule prescribing uniform testing fees across Medical Device Testing Laboratories, eliminating cost disparities and improving financial predictability for manufacturers and importers.
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EU Recognition for Clinical Waivers (Rule 63): Adds the European Union to the list of recognized regulatory bodies—joining the US, UK, Australia, Canada, and Japan—allowing clinical trial waivers for devices approved in the EU that lack a local predicate.
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Expected Sector Impact: Streamlines market access timelines, cuts administrative costs, and aligns India’s medical device framework with international regulatory standards.
