CDSCO Issues Guidance on Regulatory Pathway for AI, Software-Based Medical Devices

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30 July 2026 at 1:30 pm

CDSCO Issues Guidance on Regulatory Pathway for AI, Software-Based Medical Devices

HyperFast News

Summary

CDSCO has issued new guidance to clarify the regulatory pathway for artificial intelligence and software-based medical devices. This guidance details how these products will be regulated under the Medical Devices Rules (MDR), 2017.

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CDSCO Issues Guidance on Regulatory Pathway for AI, Software-Based Medical Devices | HyperFast News