How is AI-MedTech in India regulated?

While the CDSCO’s July 2026 guidelines on software and AI use in medical devices address some important issues, what India needs is more than guidelines: it needs a clear, statutory framework that is law

thehindu.com ·2h ago

India regulates AI-MedTech through its existing Medical Devices Rules, 2017, within a risk-based framework. However, what India needs is a clear, statutory framework that is law. The July 2026 CDSCO guidelines address some important issues but are not a new regulatory control. Doctors' digital patient acquisition is now governed by ethics rules in the National Medical Commission (NMC) due to the use of AI-generated patient testimonials.

The regulation of AI-MedTech is an urgent question of patient safety as AI increasingly influences clinical decisions.

Written by urgent.news from The Hindu - Sci-Tech's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.

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How is AI-MedTech in India regulated? thehindu.com

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