Medical device rules eased for outsourced sterilisation; EU added to stringent regulatory jurisdictions
The amendments to the Medical Devices Rules, 2017, seek to simplify regulatory requirements, standardise testing fees and facilitate faster market access for eligible medical devices
The Union Health Ministry in India has introduced amendments to the Medical Devices Rules, 2017, aiming to ease regulatory requirements and facilitate faster market access for medical devices. The proposed changes remove the need for a separate licence for outsourced sterilisation, reducing paperwork, administrative burden, and compliance costs for manufacturers lacking their own sterilisation facilities.
Manufacturers must now still specify the sterilisation facility's licence number on the device label, with a six-month transition period for implementing the changes. Additionally, the EU has been added to the list of stringent regulatory jurisdictions where clinical investigation requirements can be waived for medical devices lacking predicate devices in India.
This amendment, alongside already recognizing the US, UK, Australia, Canada, and Japan, is expected to expedite regulatory timelines and boost the competitiveness of India's medical device industry.
Written by urgent.news from The Hindu Health's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
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