CDSCO issues guidance clarifying regulatory pathway for AI, software-based medical devices
The CDSCO has issued new guidance to clarify the regulatory pathway for AI and software-based medical devices under existing Indian law. The document distinguishes between software intended for medical purposes and general wellness applications.
In a move aimed at bringing greater regulatory clarity and ensuring safety for patients, the Central Drugs Standard Control Organisation (CDSCO) has issued a guidance document for India’s fast-growing digital health sector, detailing 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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