Govt Regulations
CDSCO maps how AI medical software must clear India's device rules
By Arjun
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11 Aug 8:09 PM
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Via The Hindu
India's Central Drugs Standard Control Organisation issued guidance explaining how software medical devices, including AI and machine learning tools for diagnosis, monitoring, prediction, or treatment, fall under the Medical Devices Rules, 2017, The Hindu reported. Products face risk classes A through D, with lifecycle duties covering design, validation, cybersecurity, updates, and post-market surveillance, plus clinical evidence for the intended use. General wellness trackers sit outside the framework. Why it matters: Indian health AI finally has a clearer compliance map under existing law. Caveat: the document clarifies current practice rather than creating a brand-new AI statute.
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