India Classifies AI Cancer Software as Medical Devices

The Indian government has classified AI-driven cancer detection and diagnostic software as Class C medical devices, the Central Drugs Standard Control Organisation (CDSCO) announced, subjecting them to regulatory approval, safety validation, and continuous monitoring. The change affects tools analyzing X-rays, CT scans and other medical images and targets moderate-to-high risk products. Developers must meet prescribed quality standards and report patient-safety issues before wider clinical deployment.
Scoring Rationale
Regulatory action is official and industry-wide, enabling oversight; limited to India but likely to influence international precedent.
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