New Delhi: The Union Health Minister has amended the Medical Devices Rules, 2017, dropping the requirement for a separate loan licence in cases of outsourced sterilisation of medical devices and expanding the list of recognised stringent regulatory jurisdictions to include the European Union, it said in a public statement.
According to the ministry, “Under the amended provisions, manufacturers outsourcing product sterilization to another facility holding a valid licence under the Medical Devices Rules, 2017 will no longer be required to obtain a separate loan licence for the outsourced sterilization activity”
The ministry added that this eliminates the requirement for a separate loan licensing process in such cases and reduces duplication, administrative burden, compliance costs and associated timelines, particularly for manufacturers that do not have in-house sterilization facilities
The amended provision also provides a six-month transition period for implementation of the new labelling requirement, giving manufacturers time to update labelling and packaging before it takes effect.
The ministry also notified that it has amended Rule 63 of the Medical Devices Rules, 2017 to include the European Union (EU) among the recognized stringent regulatory jurisdictions for waiver of clinical investigation requirements for medical devices without predicate devices.
The list previous covered the United States of America, United Kingdom, Australia, Canada and Japan.
“With the inclusion of the EU, eligible medical devices that have already been approved in the EU will be able to benefit from the waiver provisions, facilitating faster patient access to advanced medical technologies in India”, the ministry said.
The move comes after India-EU Free Trade Agreement (FTA) was signed in January this year. The FTA brings significant tariff cuts on European medical devices and is set to to reduce compliance burden on European multinationals.
In June this year, Union Commerce and Industry Minister Piyush Goyal led a delegation to Switzerland, accompanied by senior regulatory officials to advance the FTA and economic partnership agreement.
Currently, India has a high-import dependency in the medical devices sector and around 80-85 per cent of total device requirement is met through imports. In FY26, imports surged 17 per cent year-on-year to Rs 89,000 crore, largely driven by high-risk, technology-intensive products.
