EU approval recognised for faster medical device access in India
NEW DELHI: Patients in India may gain faster access to certain newer medical devices already approved in the European Union, following a government move to broaden the list of trusted foreign regulators and simplify sterilisation-related licensing requirements.
The Health Ministry has amended the Medical Devices Rules, 2017 to include the European Union among jurisdictions recognised for a waiver of clinical investigation requirements for eligible medical devices that do not have a predicate device in India. The list earlier included the United States, the United Kingdom, Australia, Canada and Japan.
The change means that eligible devices with EU regulatory approval can potentially avoid a fresh clinical investigation in India, reducing the time and regulatory steps before they can be made available to patients. The waiver remains subject to conditions prescribed under the rules.
According to the government, the move will reduce regulatory timelines for manufacturers and importers and facilitate faster availability of advanced medical technologies in India. The addition of the EU also aligns India’s medical-device regulatory framework more closely with international practices.
In a separate amendment, manufacturers who outsource sterilisation to a facility with a valid licence will no longer need a separate loan licence. This change reduces paperwork, compliance costs, and delays for manufacturers. However, they will still have to print the sterilisation facility’s licence number on the device label, with six months given for compliance. The labelling requirement had earlier drawn industry concerns over added compliance burden and possible export delays.
The government has also introduced a standard fee schedule for testing and evaluation of medical devices. The new charges include Rs 5,000 for implantation tests, Rs 2,000 for sterility testing, Rs 1,000 for syringes and needles, and Rs 3,000 for surgical sutures. Testing fees for condoms and intrauterine devices have been fixed at Rs 2,500 each.
For tests not specified in the schedule, the charges will be decided by the concerned laboratory or medical device testing officer. The prescribed fees will automatically rise by 5 per cent annually.
The three changes are aimed at cutting regulatory duplication, making compliance costs more predictable, and speeding up access to medical devices while retaining requirements for quality, safety, and traceability. The sterilisation and testing-fee amendments were notified as the Medical Devices (Second Amendment) Rules, 2026.
