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.
The Central Drugs Standard Control Organisation (CDSCO) in India has released guidance to clarify the regulatory pathway for software-based medical devices, including those utilizing artificial intelligence (AI). This move aims to ensure patient safety in the rapidly expanding digital health sector. The guidance clarifies how software products will be regulated under the Medical Devices Rules (MDR), 2017, while excluding software for general wellness or fitness tracking.
CDSCO emphasizes that AI and machine learning-based software will be classified into risk categories, with higher-risk products facing more stringent regulatory scrutiny. The document outlines a lifecycle approach to regulation, covering software design, verification, validation, cybersecurity, updates, maintenance, and post-market surveillance.
The guidance provides a clearer compliance roadmap for AI companies, reducing regulatory uncertainty and potentially facilitating wider adoption of AI products in healthcare by healthcare providers.
Written by urgent.news from The Hindu Health's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
