The Union Ministry of Health and Family Welfare has proposed key regulatory reforms in the medical device sector, aimed at easing licensing requirements for outsourced sterilisation and expanding the list of recognised stringent regulatory jurisdictions eligible for clinical investigation waivers, as reported by Press Information Bureau (PIB).
The measures, aimed at promoting ease of doing business, are expected to simplify regulatory processes, reduce compliance costs and timelines, and facilitate faster access to advanced medical technologies in India.
The government has proposed amendments to the Medical Devices Rules, 2017, including Rule 44, which governs certain requirements related to outsourced sterilisation activities.
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Under the amended provisions, medical device manufacturers that outsource product sterilisation 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 sterilisation activity.
The proposed amendment was finalised following extensive stakeholder consultations and is intended to simplify regulatory compliance for manufacturers using outsourced sterilisation facilities.
By removing the separate loan licensing requirement, the government aims to reduce duplication, administrative burden, compliance costs and associated timelines, particularly for manufacturers that do not have in-house sterilisation facilities.
Manufacturers will also get a six-month transition period to implement the new labelling requirement. The transition period will allow companies to make the necessary changes to their labelling, packaging and related processes before the provision comes into effect.
The government said the revised framework seeks to balance regulatory oversight with ease of doing business by simplifying the licensing process while retaining an essential traceability mechanism for outsourced sterilisation.
The move is expected to provide greater operational flexibility to manufacturers, facilitate faster and more efficient manufacturing processes, and support the growth and competitiveness of India’s medical device industry.
Separately, an amendment of Rule 63 of the Medical Devices Rules, 2017 has been proposed to include the European Union among the recognised stringent regulatory jurisdictions for waiver of clinical investigation requirements for medical devices without predicate devices.
The provision currently recognises the United States, United Kingdom, Australia, Canada and Japan, according to the report.
The EU’s inclusion will allow qualified medical devices that have previously received EU approval to take advantage of the waiver provisions, which might speed up patient access to cutting-edge medical advances in India.
The amendment is also expected to reduce the regulatory burden and associated timelines for importers and manufacturers, while strengthening international regulatory convergence in the medical device sector.
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Overall, the reforms are aimed at simplifying regulatory processes, reducing costs and enhancing transparency and predictability, while facilitating the timely availability of advanced and innovative medical devices in India.
The measures mark another step towards strengthening India’s medical device regulatory ecosystem and promoting greater ease of doing business, while continuing to maintain standards of quality, safety and performance for medical devices.
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