EU-approved medical devices' imports may be eased
medical devices in the country, the government may do away with the requirement of clinical investigation of those devices approved in the European Union (EU), people aware of the proposal told ET.
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Already, India has waived medical devices approved by regulatory authorities of the US, UK, Australia, Canada and Japan from clinical investigation requirements.
The proposal for inclusion of the EU to this list will be taken up at the next meeting of the Drugs Technical Authority Board (DTAB), India's highest advisory body on drugs under the drug regulator, a government document said.
ET has seen a copy of the document.
If approved, the government will amend Rule 63(1) of the Medical Devices Rules, 2017, for inclusion of the EU.
The matter has been under consideration since 2018, when, during the meeting of the India-EU sub-commission on trade, the EU officials said that for the regulation of new products, the new regulations stated that clinical investigation may not be required to be submitted where the investigational medical device is approved by the regulatory authorities of the US, UK, Australia, Canada or Japan, but did not include the EU, as per Rule 63(1).
The proposal was sent to the health ministry for amendment to Rule 63(1) in 2021.
