New Delhi, 24 August (H.S.):The Central Government has amended the Medical Devices Rules, 2017, with the aim of improving ease of doing business in the medical devices sector. The changes are intended to simplify regulatory procedures, reduce the compliance burden and facilitate faster availability of advanced medical devices in India.

The Ministry of Health and Family Welfare said in a statement on Monday that under the revised provisions, manufacturers will no longer be required to obtain a separate loan licence for outsourced sterilisation activities if they have their products sterilised at another facility that already holds a valid licence. Outsourced sterilisation refers to the use of an external licensed agency or facility to sterilise medical devices or other materials.

The move is expected to eliminate duplication in the licensing process, reduce administrative and compliance costs and shorten processing timelines. It is likely to particularly benefit manufacturers that do not have their own sterilisation facilities.

The amendment also provides a six-month transition period for implementing the new labelling requirements. During this period, manufacturers will be able to make the necessary changes to their labelling, packaging and related processes.

The Ministry has also amended Rule 63 of the Medical Devices Rules, adding the European Union (EU) to the list of jurisdictions recognised as stringent regulatory authorities. This will enable eligible medical devices already approved in the EU to avail themselves of an exemption from certain clinical investigation requirements in India.

The list previously included the United States, the United Kingdom, Australia, Canada and Japan.

The government said the changes would facilitate faster access to advanced and innovative medical devices in India while maintaining regulatory standards related to quality, safety and performance.

According to the Ministry, the reforms are expected to enhance transparency, regulatory predictability and competitiveness in the medical devices industry while further promoting ease of doing business.

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Hindusthan Samachar / Jun Sarkar