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. 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…
