India plans to fast-track EU-approved medical devices, allowing them to bypass redundant clinical trials, boosting market availability and streamlining regulatory processes.
The Indian government and the Drugs Technical Authority Board (DTAB) proposed for inclusion of the EU to this list will be taken up at the next meeting of the Drugs Technical Authority Board (DTAB). India has previously waived clinical investigation requirements for medical devices approved by regulatory authorities in the US, UK, Australia, Canada, and Japan.
If approved, the government will amend Rule 63(1) of the Medical Devices Rules, 2017, to include the EU. The consideration of this matter dates back to 2018 when, during a meeting of the India-EU sub-commission on trade, EU officials highlighted that their new regulations allowed for the waiver of clinical investigation requirements for devices approved by the US, UK, Australia, Canada, or Japan but did not extend this waiver to EU-approved devices as per Rule 63(1).
In 2021, the proposal to amend Rule 63(1) was sent to the health ministry, which then referred it back to the Central Drugs Standard Control Organisation (CDSCO) for further review in light of updated rules and recent notifications. The ministry also called for consultations with the DTAB for a fresh proposal.
