The Ministry of Health and Family Welfare announced on Monday that it has undertaken regulatory reforms in the medical device sector to promote ease of doing business.According to the statement by the ministry, the reforms are aimed at simplifying regulatory requirements, enhancing transparency and facilitating timely access to advanced and innovative medical technologies in the country.“The reforms include amendments to the Medical Devices Rules, 2017 in three key areas—simplification of provisions relating to outsourced sterilisation of medical devices, introduction of uniform testing fees and inclusion of the European Union among recognized jurisdictions for waiver of clinical investigation requirements,” said the release.The Ministry said, manufacturers who had earlier lacked an in-house sterilisation facility were required to obtain a separate loan licence for sterilisation activities.The amended provision aims to ease regulatory compliance requirements, documentation, approval timelines and associated costs, while enabling manufacturers to efficiently avail specialised sterilisation facilities.Additionally, it noted that an additional schedule has been added to the Medical Devices Rules, 2017 which prescribes a uniform fee for testing of medical devices by Medical Device Testing Laboratories.“Further, a Ninth Schedule has been inserted in the Medical Devices Rules, 2017 prescribing uniform fees for the testing of medical devices by Medical Device Testing Laboratories. The measure will establish a standardised and transparent fee structure across laboratories, reducing ambiguity and variations in testing charges,” said the Health Ministry.The standardised fee structure is aimed at providing greater predictability to manufacturers and importers, minimising disputes, ensuring equitable treatment of stakeholders and further strengthening transparency and efficiency in the medical device regulatory framework.Further, the statement said Rule 63 of the Medical Devices Rules, 2017 was amended to include the European Union (EU) into the list of countries recognised under stringent regulatory jurisdictions for waiver of clinical investigation requirements for medical devices without predicate devices.The United States, United Kingdom, Australia, Canada and Japan are already recognised under the provision.The Health Ministry said the inclusion of the European Union will allow faster access in India to eligible medical devices that have already been approved in the EU, whilst reducing regulatory requirements and timelines for importers and manufacturers.