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 approved in India.The amendment to Rule 63 of the Medical Devices Rules-2017 allows manufacturers to bypass domestic clinical trial requirements for all new medical devices provided these have the approval of the recognised global authority in the jurisdictions the rule lists.By this amendment, India has added the EU to the list of global regulatory authorities whose approvals are enough for Indian manufacturers to skip local trials. The already listed jurisdictions in this rule are the US, the UK, Australia, Canada and Japan.How amendment helpsBy cutting down on local trial requirement for new medical devices, the government seeks to ensure faster market access of cutting-edge imported devices in India.The move will reduce costly repetitive trials, translating into lower cost.Major imported devices include electronic and imaging equipment such as MRI scanners, CT scan systems, PET systems used for cancer diagnostics, as well as life-saving products such as pacemakers, implantable cardioverter-defibrillators and orthopaedic implants used in joint replacement surgeries.Official sources said the change would hasten the market access of new medical technologies for patients and allow lowering of prices by cutting down on repetitive testing. “Alignment with global regulatory standards ensures safety while keeping the need for quality standards high and ensuring quick market access to cutting-edge devices,” said a Health Ministry source.In another major amendment (to Rule 44), manufacturers who lack in-house sterilisation facilities for manufactured medical devices will no longer require a separate licence to outsource the product for sterilisation. This was a long-standing demand of the sector.The provision will ease regulatory compliance requirements for manufacturers and boost the industry with a goal on self-reliance.At present, India imports about 80 per cent of its medical device requirement, with some industry estimates placing the annual import bill at USD 8.6 billion.