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 pres
