The Union Ministry of Health and Family Welfare (MoHFW) has proposed amendments to the Medical Devices Rules, 2017, aimed at simplifying regulatory requirements, improving transparency and facilitating faster market access for eligible medical devices.
The proposed reforms cover three key areas – outsourced sterilisation of medical devices, standardisation of testing fees and recognition of the European Union as a stringent regulatory jurisdiction for waiving clinical investigation requirements.
Under the amended provisions of Rule 44, manufacturers using outsourced sterilisation facilities will no longer need to obtain a separate loan licence under Rule 25, provided the sterilisation facility has a valid licence under the Medical Devices Rules, 2017.
Earlier, manufacturers without in-house sterilisation facilities were required to obtain a separate loan licence for sterilisation activities. The change is expected to reduce compliance requirements, documentation, approval timelines and associated costs, while making it easier for manufacturers to use specialised sterilisation facilities.
The amendments also introduce a Ninth Schedule prescribing uniform testing fees for medical devices tested by Medical Device Testing Laboratories. The standardised fee structure is intended to bring greater transparency and consistency to testing charges across laboratories.
According to the ministry, the move will provide manufacturers and importers with greater predictability, reduce ambiguity and disputes over testing charges, and promote equitable treatment of stakeholders.
In another major change, Rule 63 of the Medical Devices Rules, 2017 has been amended to include the European Union among the recognised stringent regulatory jurisdictions for waiving clinical investigation requirements for certain medical devices without predicate devices.
The provision currently recognises the United States, United Kingdom, Australia, Canada and Japan. With the inclusion of the EU, eligible medical devices that have already received approval in the European Union could gain faster access to the Indian market, while reducing regulatory burdens and timelines for manufacturers and importers.
The Ministry said the reforms are expected to lower compliance costs, simplify regulatory processes and improve transparency and predictability in the medical device sector.
The measures are also aimed at promoting greater international regulatory convergence while maintaining high standards of quality, safety and performance of medical devices, the ministry said.
The reforms form part of the government’s broader efforts to promote Ease of Doing Business in the medical device sector and facilitate timely availability of advanced and innovative medical technologies
