AnyTime News 
Pooja Srivastava | Anytime News Network
The Union Ministry of Health and Family Welfare has proposed major reforms to the regulatory framework governing medical devices in India, aimed at simplifying legal requirements, improving transparency and facilitating faster access to modern and innovative medical technologies.
The proposed changes to the Medical Devices Act, 2017 focus on three key areas: outsourcing of sterilisation, uniform testing fees and clinical investigation requirements involving international regulatory authorities.
Under the first reform, provisions related to the outsourcing of medical device sterilisation have been simplified. Manufacturers using an authorised facility for sterilisation will now be required to mention the licence number of the licensed facility at the device level. The move is expected to improve accountability and strengthen traceability within the medical device supply chain.
The second major change proposes uniform testing fees for medical device testing laboratories. The charges will be specified under the Ninth Schedule of the Medical Devices Rules. A standardised fee structure is expected to bring greater transparency and reduce variations in testing costs across laboratories.
A significant amendment has also been proposed to Rule 63, under which the European Union would be added to the list of international regulatory authorities recognised under the mechanism. The existing list includes the United States, United Kingdom, Australia, Canada and Japan.
The inclusion of the European Union could reduce the need for separate clinical investigations in India for certain medical devices that have already been approved in the EU. This is expected to speed up access to advanced medical technologies while reducing regulatory and legal burdens for importers and manufacturers.
The government stated that the reforms are aimed at strengthening the legal framework for medical devices while maintaining high standards of safety, quality and performance. The measures are also expected to support innovation and improve the ease of doing business in India’s rapidly expanding healthcare technology sector.
The proposed amendments mark an important step towards creating a more streamlined, predictable and technology-friendly regulatory environment for medical device manufacturers and healthcare stakeholders.
