According to persons familiar with the topic, the administration is considering eliminating the necessity for clinical evaluation of devices approved in the European Union (EU) to accelerate the availability of innovative medical devices in the country.
So far, the government has exempted clinical investigation requirements in cases when regulatory agencies in the United States, United Kingdom, Australia, Canada, and Japan have approved the medical device.
According to sources, the Drugs Technical Authority Board (DTAB), India’s highest drug advisory body, will soon consider the move to include the EU in addition to the present countries. According to the people, the government is likely to change Rule 63(1) of the Medical Devices Rules, 2017, to include the EU.
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Rule 63(1) Update: Ministry Refers to CDSCO:
The issue has been discussed since 2018, when EU officials stated that clinical investigations may not be required for investigational medical devices approved by regulatory authorities in the US, UK, Australia, Canada, or Japan. However, the EU was not included in the new regulations, as per Rule 63(1).
The health ministry received the request to alter Rule 63(1) in 2021. It did, however, refer the matter back to the Central Drugs Standard Control Organization (CDSCO) for a thorough examination in light of the most recent notifications and revised regulations. To develop a new plan, the ministry also requested discussions in consultation with the DTAB.
Upcoming DTAB Review: Rule 63(1) EU Change
“The proposal to amend Rule 63(1) of the Medical Devices Rules, 2017 for inclusion of EU in addition to the already mentioned countries will be placed in e the forthcoming DTAB meeting for re-deliberation and for taking necessary e action in the matter,” stated in a government document. A copy of the aforementioned paper has been seen by ET.
