The matter has been discussed since 2018, the regulation of new products does not involve clinical investigations if Investigational Medical Device is approved by the Authorities of the United States, Australia, Canada and Japan but not in EU as per rule 63 (1).

New Delhi: Sources close to the proposal say that to further increase the time taken to bring new medical devices into the country, the government may remove the need for clinical investigations of EU approved devices.

India has already exempted clinical investigation for the approved medical devices from the mentioned countries of the USA, UK, Australia, Canada & Japan respectively.The proposal to include the EU on this list will be discussed at the next meeting of the Drugs Technical Authority Board (DTAB), India's highest advisory body on drugs under the drug regulator, according to a government document seen by ET.

The EU will be added to Rule 63(1) of the Medical Devices Rules, 2017 by the government if it is accepted. We have considered the matter since 2018, when, during the meeting of the India-EU sub-commission on trade, EU officials said new regulations might not require clinical investigations if the investigational medical device is approved by the regulatory authorities of the US, UK, Australia, Canada, or Japan, but they did not include the EU, as per Rule 63(1).

We sent the proposal to the health ministry for amendment to Rule 63(1) in 2021. However, the ministry referred it back to the Central Drugs Standard Control Organisation (CDSCO) for a critical review in the context of updated rules and recent notifications. In order to create a new plan, the ministry also requested discussions in consultation with DTAB.

Rajiv Nath, forum coordinator of the Association of Indian Medical Devices Industry, recommended that if India plans to grant waivers or fast-track regulatory approval to EU-based manufacturers, it should negotiate a reciprocal trade agreement with the EU instead of merely amending its Medical Devices Rules. He emphasized, "India should seek reciprocal acceptance from the EU for fast-track regulatory approval of CDSCO-licensed or QCI's ICMED-certified Indian manufacturers. The EU, CDSCO, and QCI can collaboratively cross-map and verify each other's regulatory provisions and audit control effectiveness before establishing a mutual regulatory agreement (MRA)."