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.
Why it matters
Clear regulatory frameworks are essential for the growth of the digital health sector and ensuring patient safety in AI-driven medical technologies.
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.
The guidance is intended to help manufacturers, importers, innovators and researchers prepare applications for regulatory approval from the licensing authority. It applies to software products under the definition of a medical device. It, however, does not apply to software merely intended for general wellness, promoting a healthy lifestyle, or measure body parameters only for regular tracking and fitness purposes.
“This Guidance Document reflects current practices under the MDR-2017 and should not be misconstrued as a new regulatory control on Medical Device Software (MDSW), including In-vitro Diagnostic (IVD) MDSW,” CDSCO noted in its announcement.
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