Software that uses artificial intelligence (AI) or machine learning (ML) technologies to perform one or more medical functions is known as Artificial Intelligence Software as a Medical Device (AI-SaMD). Diagnosis, disease prediction, clinical decision-making, medical image analysis, patient monitoring, treatment planning, and other healthcare-related tasks may be supported by these technologies.
Support for organizations assessing software as a medical device, determining the appropriate CDSCO pathway, and preparing for regulatory submission and market access.
Structured support for assessing regulatory applicability, preparing AI-enabled medical software submissions, and maintaining post-approval compliance.
Practical regulatory support for AI-enabled healthcare software, from classification and documentation to approval readiness and market access.
FAQ
AI-SaMD products are classified based on their intended purpose, level of risk, and potential impact on patient health. CDSCO follows a risk-based classification system ranging from Class A to Class D.
Yes. However, significant software modifications or algorithm changes may require regulatory notification or approval depending on their impact on safety and performance.
Yes. Manufacturers are expected to monitor product performance, manage complaints, investigate adverse events, and maintain ongoing regulatory compliance after market entry.
Yes. Manufacturers are generally expected to establish and maintain an appropriate Quality Management System to support product development, risk management, regulatory compliance, and post-market activities.
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