Medical Device Rules Eased for Outsourced Sterilisation; EU Added to Stringent Regulatory Jurisdictions

EU approvals, easier sterilisation rules to speed device access

India News: NEW DELHI: Patients in India could get faster access to some newer medical devices already approved in the European Union, with the government expandi.

New medical devices approved in EU wont need India trial - The Tribune

New medical devices approved by the European Union’s apex drug regulator will no longer require a trial in India.The government on Monday amended the rules governing medical devices sector in India to include the EU among stringent regulatory jurisdictions recognised for waiving clinical trials for new medical devices, provided a similar device is not already […]

Govt eases medical device rules, speeds access to EU-approved products

Amendments to India's medical devices rules allow manufacturers to outsource sterilization without obtaining a separate loan licence if the third-party facility is already licensed.

Medical device firms get relief from separate licence for outsourced sterilisation

Earlier, manufacturers had to obtain a separate loan licence even when they sent their products to an outside sterilisation facility that was already licensed under the rules

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

Red Tape Cut: India Streamlines Medical Device Rules to Fast-track Innovation

Get latest articles and stories on India at LatestLY. India's Union Ministry of Health and Family Welfare has officially rolled out targeted amendments to the Medical Devices Rules, 2017, designed to boost Ease of Doing Business (EoDB), eliminate regulatory bottlenecks, and accelerate consumer access to advanced healthcare tech. India News | Red Tape Cut: India Streamlines Medical Device Rules to Fast-track Innovation.