India’s Central Drugs Standard Control Organisation (CDSCO) has issued a notification classifying AI-based cancer detection and diagnostic software as Class C medical devices, placing them under formal regulatory control.
Class C devices are considered moderate to high risk, meaning AI tools used for cancer diagnosis and screening in hospitals, diagnostic centers, and research institutions will now require regulatory approval, safety validation, and continuous monitoring before clinical use.
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Under this regulatory framework, developers of AI-powered cancer diagnostic solutions must:
Obtain CDSCO approval prior to deployment
Demonstrate safety, performance, and clinical relevance
Implement quality management systems
Conduct post-market surveillance and vigilance reporting
Address patient safety risks proactively
The classification list will be reviewed periodically by the Central Drugs Medical Organization (CDMO) as AI-driven healthcare technologies evolve.
Experts have welcomed the move, noting that regulatory oversight is critical to ensure the ethical and responsible use of AI in medical diagnostics. AI technologies have shown strong potential in the early detection of cervical, lung, and breast cancers, but challenges remain—particularly the limited availability of large, representative Indian clinical datasets required for reliable AI validation.
By bringing rapidly evolving AI technologies under legal scrutiny, CDSCO aims to protect patient safety while enabling controlled innovation. This step is also expected to set a regulatory precedent for future AI-based medical technologies in India.
AI-led cancer research continues to advance rapidly. Recently, researchers at the Indraprastha Institute of Information Technology (IIIT) Delhi reported progress in early-stage cancer detection using AI-enabled blood testing methods, as reported by NDTV Profit.
Unsure if your AI cancer diagnostic software qualifies as Class C under CDSCO?
Role of Operon Strategist
Operon Strategist supports AI medical software developers and healthcare technology companies in navigating CDSCO regulatory pathways for AI-based diagnostic solutions. The team assists with software classification, risk management documentation, clinical evaluation strategies, ISO 13485 and IEC 62304 compliance, regulatory submissions, and post-market surveillance frameworks, helping innovators achieve compliance while ensuring patient safety and faster market access.
