This presentation provides a clear and practical overview of CDSCO registration for Software as a Medical Device (SaMD) in India, helping healthtech startups, medical software companies, and regulatory professionals understand the compliance requirements under Indian regulations. As digital health solutions continue to expand, software intended for medical purposes is increasingly regulated as a medical device, making regulatory awareness essential before market entry. The document explains the concept of Software as a Medical Device (SaMD), including common healthcare applications such as diagnostic software, clinical decision support tools, and patient monitoring solutions. It outlines how SaMD is regulated in India under the Medical Device Rules, 2017, and the role of the Central Drugs Standard Control Organization (CDSCO) in overseeing approval and registration. Key sections cover risk-based classification of SaMD, explaining how intended use and patient impact determine regulatory obligations. The presentation also highlights when CDSCO registration is required, who must apply, and the situations in which manufacturers, developers, or importers are responsible for compliance. To support regulatory readiness, the presentation outlines the key documentation required for SaMD registration, including technical documentation, software development lifecycle records, validation and verification evidence, risk management files, and quality system documentation. It also provides an overview of the approval process and typical regulatory checkpoints, helping organizations anticipate timelines and review stages. Common challenges faced during SaMD compliance—such as documentation gaps, software validation complexity, and regulatory interpretation issues—are discussed to help organizations prepare proactively. The presentation emphasizes the value of expert regulatory guidance in ensuring accurate classification, complete submissions, and smooth interaction with regulatory authorities. Designed for healthtech startups, medical software companies, regulatory professionals, and digital health innovators, this presentation serves as an educational resource for understanding CDSCO SaMD requirements in India and building compliant, regulatory-ready digital health products. For additional reference on CDSCO SaMD registration and regulatory guidance, visit: https://operonstrategist.com/services/regulatory-approvals/cdsco-registration-for-software-as-a-medical-device-samd-in-india/