India CDSCO Medical Device Software Guidance

India's CDSCO released final guidance on medical device software (MDSW) on July 21, 2026, including an Algorithm Change Protocol for AI/ML updates and a new Risk Classification Module for non-IVD devices. Additionally, India sanctioned 1,500 new CDSCO posts targeting software/AI expertise, and the EU joined the trusted list for faster approvals—signaling regulatory maturation and harmonization. This affects market access and post-market management for software manufacturers in India.