Centre simplifies medical device approval process, eases sterilisation norms - The Tribune
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The Centre has introduced amendments to the Medical Devices Rules, 2017, to reduce delays and make the approval process for medical devices simpler and faster without removing safety checks.
Under the amended provisions, manufacturers outsourcing product sterilisation to another facility holding a valid licence will no longer be required to obtain a separate loan licence for the outsourced sterilisation activity.
At present, manufacturers that do not have an in-house sterilisation facility are required to obtain a separate loan licence for sterilisation activities. Outsourcing sterilisation means a medical device company sends its products to another specialised facility to make them germ-free and safe for use. For instance, if Company X manufactures surgical instruments, Company Y sterilises them, after which Company X gets them back and sells them.
“Earlier, medical device manufacturers had to obtain a separate loan licence if they got their products sterilised by an outside facility. This was an additional regulatory requirement, even when the sterilisation facility itself already had a valid licence under the Medical Devices Rules, 2017. Now, the Government has changed this requirement. The manufacturer does not need a separate loan licence for outsourced sterilisation, as long as the sterilisation facility has a valid licence under the Medical Devices Rules, 2017. However, the licence number of the sterilisation facility must be mentioned on the medical device label,” a Health Ministry official explained.
He said the change is aimed at simplifying compliance, reducing unnecessary paperwork and supporting Ease of Doing Business for the medical device industry.
Until now, India allowed certain medical devices to skip a separate clinical investigation in the country if they had been approved by regulators in certain countries considered to have stringent safety standards. The recognised jurisdictions were the US, UK, Australia, Canada and Japan. The Government now wants to add the European Union (EU) to this list.
Under the proposed change, if a new medical device has already undergone the required regulatory process and been approved for use in the EU, the company may not have to conduct another clinical investigation in India to establish the device’s safety and performance, provided it meets India’s eligibility conditions.
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- tribuneindia.com (2026-08-24) - Original article: Centre simplifies medical device approval process, eases sterilisation norms - The Tribune