Overview
- The CDSCO issued a notification placing AI tools for cancer detection and diagnosis under Class C, a moderate-to-high risk category for medical devices.
- Developers must secure regulatory approval, complete safety validation, maintain continuous post-market monitoring, and report patient-safety issues under quality standards.
- Some products are already used in limited clinical settings, yet experts note most remain research-stage in India due to scarce, representative local datasets.
- AIIMS preventive oncology specialist Dr Pallavi Shukla welcomed the move as essential for ethical use and patient protection in cancer screening.
- Officials say the step could guide oversight of other AI medical software, with the risk-classification list slated for periodic updates as technology evolves.