Govt Regulations
India maps AI diagnostic software into medical-device licensing rules
By Arjun
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5 Aug 8:08 PM
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Via The Hindu
India's Central Drugs Standard Control Organisation issued final guidance on how medical device software, including AI and machine learning tools for diagnosis, monitoring, prediction, or treatment, is regulated under the Medical Devices Rules, 2017. Standalone clinical software and software inside devices are treated separately, following IMDRF-style ideas, and AI products fall into risk Classes A through D. General wellness and fitness apps stay outside the scope. The guidance stresses lifecycle validation, cybersecurity, updates, and post-market monitoring. Why it matters: Indian AI health developers get a clearer licensing path. Caveat: CDSCO says this clarifies existing rules, not a brand new statute.
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