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CDSCO issues guidance clarifying regulatory pathway for AI, software-based medical devices

It elaborates how software-based medical devices, including artificial intelligence (AI)-enabled products, will be regulated under the Medical Devices Rules (MDR), 2017.

· 7/29/2026, 12:24:08 PM· 2 min read
CDSCO issues guidance clarifying regulatory pathway for AI, software-based medical devices
It elaborates how software-based medical devices, including artificial intelligence (AI)-enabled products, will be regulated under the Medical Devices Rules (MDR), 2017.
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