India Considers Waiving Clinical Trials for EU-Approved Medical Devices

If approved, this would result in an amendment to Rule 63 (1) of the Medical Devices Rules, 2017, to formally include the EU in the waiver list.

In a move to expedite the availability of medical devices in India, the government is considering eliminating the requirement for clinical investigations of devices that have already been approved by the European Union (EU).

This follows similar waivers granted to devices approved by regulatory authorities in the United States, United Kingdom, Australia, Canada, and Japan.

According to a government document reviewed by ET, the proposal to include the EU in this list will be discussed at the next meeting of the Drugs Technical Authority Board (DTAB), India's top advisory body on drug regulation.

If approved, this would result in an amendment to Rule 63 (1) of the Medical Devices Rules, 2017, to formally include the EU in the waiver list.

Background & Ongoing Deliberations

This proposal was considered in 2018 when discussions during a meeting of the India-EU subcommission on trade highlighted the EU's exclusion from a list of countries whose medical device approvals could bypass clinical investigations in India.

The EU officials noted that under current regulations, devices approved by regulatory bodies in the US, UK, Australia, Canada, and Japan are exempt from clinical investigations in India, but the EU was not included.

The proposal was forwarded to the Ministry of Health in 2021 for the necessary amendment to Rule 63 (1). However, the Ministry referred it back to the Central Drugs Standard Control Organisation (CDSCO) for further review, considering updated regulations and recent notifications.

The Ministry also requested further deliberations with the DTAB for a fresh proposal.

Call for Reciprocal Arrangements

Rajiv Nath, forum coordinator of the Association of Indian Medical Devices Industry, suggested that India should seek reciprocal acceptance of Indian medical devices in the EU market in exchange for waiving clinical trials for EU-approved devices.

Nath further proposed that India should negotiate a mutual regulatory agreement (MRA) with the EU to ensure that Indian manufacturers with CDSCO licenses or QCI's ICMED certifications receive similar fast-track approvals in the EU.

"India needs to seek reciprocal acceptance by the EU of fast-track regulatory approval for CDSCO-licensed or QCI's ICMED-certified Indian manufacturers too," Nath emphasized.

He also suggested that the EU, CDSCO, and QCI jointly verify and cross-map each other's regulations and audit controls to establish a robust MRA.