India’s Central Drugs Standard Control Organization (CDSCO) released its finalized Guidance Document on Medical Device Software (The Guidance Document) on July 21, 2026. The Guidance Document provides comprehensive guidance dedicated to the regulation of medical device software (MDSW) under India’s existing Medical Devices Rules, 2017 (MRD-2017). It applies to Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and MDSW used for in vitro diagnostic (IVD) purposes.
The Guidance Document provides manufacturers and importers with a detailed framework for regulatory compliance. It covers regulatory and licensing pathways, intended-use statements, risk classification, technical documentation, quality management systems, clinical evidence, cybersecurity, and post-market obligations.
Key provisions include detailed guidance on applying the MDR-2017’s risk-based classification framework to MDSW, clarification of which software functions may qualify as medical devices, and separate regulatory pathways for MDSW and IVD MDSW. The Guidance Document also sets out extensive software lifecycle and technical-documentation expectations and references internationally recognized ISO and IEC standards.
In addition, the Guidance Document includes AI-specific considerations concerning risk management, training and validation datasets, retraining, and algorithm changes. It also addresses cybersecurity across product development and software updates, and provides more detailed guidance on post-market surveillance and vigilance expectations.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.