Regulatory Pathway for AI-Driven Medical Devices: Bridging Training, Validation, and Clinical Evaluation

This session is being convened to align the development, validation, and deployment of AI-enabled medical devices with India's evolving regulatory landscape. The session will examine AI-SiMD and AI-SaMD across the full lifecycle, including data quality, algorithm training, change management, technical and clinical validation, human oversight, and patient safety. Leveraging particular ongoing reasearch initiatives and draft guidance, it will foster informed, multi-stakeholder dialogue to support safe, effective, and regulation-compliant AI adoption.