- Artificial Intelligence in Medical Technology (AI-MedTech) is increasingly playing a pivotal role in diagnostics, patient care, and clinical workflows in India. - Regulation of AI-MedTech devices in India falls under the framework of medical devices regulation, primarily governed by the Central Drugs Standard Control Organization (CDSCO) and the Medical Devices Rules. - Software as a Medical Device (SaMD) faces unique regulatory challenges concerning continuous learning algorithms, data privacy, liability, and validation standards. - Balancing innovation with patient safety requires evolving regulatory sandboxes, robust clinical data protection frameworks, and transparent oversight mechanisms. - **Drugs and Cosmetics Act:** The primary legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics, providing the overarching statutory authority under which medical devices and AI-MedTech are regulated. - **Medical Devices Rules:** Rules notified under the Drugs and Cosmetics Act that establish a risk-based classification system (Classes A, B, C, and D) for medical devices, including software as a medical device (SaMD). - **Central Drugs Standard Control Organization (CDSCO):** The national regulatory body in India responsible for regulating drugs, medical devices, and diagnostics, ensuring safety, efficacy, and quality standards through frameworks like the Drugs and Cosmetics Act. **Introduction** The article explores the evolving regulatory landscape of Artificial Intelligence-driven Medical Technology (AI-MedTech) in India. It highlights how software and AI tools used for clinical diagnosis and healthcare delivery are classified and regulated under medical device frameworks, addressing key challenges such as data privacy, algorithm updates, safety validation, and the balance between fostering technological innovation and protecting patient rights. **Core Issue and Detailed Points** - Artificial Intelligence in Medical Technology (AI-MedTech) is increasingly playing a pivotal role in diagnostics, patient care, and clinical workflows in India. - Regulation of AI-MedTech devices in India falls under the framework of medical devices regulation, primarily governed by the Central Drugs Standard Control Organization (CDSCO) and the Medical Devices Rules. - Software as a Medical Device (SaMD) faces unique regulatory challenges concerning continuous learning algorithms, data privacy, liability, and validation standards. - Balancing innovation with patient safety requires evolving regulatory sandboxes, robust clinical data protection frameworks, and transparent oversight mechanisms. **Key Statutory Bodies, Acts & Concepts** - **Drugs and Cosmetics Act:** The primary legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics, providing the overarching statutory authority under which medical devices and AI-MedTech are regulated. - **Medical Devices Rules:** Rules notified under the Drugs and Cosmetics Act that establish a risk-based classification system (Classes A, B, C, and D) for medical devices, including software as a medical device (SaMD). - **Central Drugs Standard Control Organization (CDSCO):** The national regulatory body in India responsible for regulating drugs, medical devices, and diagnostics, ensuring safety, efficacy, and quality standards through frameworks like the Drugs and Cosmetics Act.