India may waive clinical investigation rule for EU-approved medical devices: Report

If approved, the government will amend Rule 63(1) of the Medical Devices Rules, 2017, to include the EU.

Medical devices that have the approval from the European Union (EU) authorities may soon be relieved of repeat investigation in India as the government plans to speed up their availability in the market, The Economic Times reported.

India has previously waived clinical investigation requirements for medical devices approved by regulatory authorities in the US, UK, Australia, Canada, and Japan. The proposal to include the EU in this list will be discussed at the upcoming meeting of the Drugs Technical Authority Board (DTAB), the highest advisory body on drugs in India under the drug regulator. The Economic Times has reviewed a government document detailing this proposal, although Moneycontrol has not independently verified the report.

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.

Rajiv Nath, forum coordinator of the Association of Indian Medical Devices Industry, suggested that if India is to grant waivers or fast-track regulatory approvals to EU-based manufacturers, the country should negotiate a reciprocal trade agreement with the EU rather than unilaterally amending its Medical Devices Rules.