Medical Software Compliance Digest

India CDSCO Medical Device Software Guidance

India CDSCO Medical Device Software Guidance

India's CDSCO released final guidance on medical device software (MDSW) in March 2026, including an Algorithm Change Protocol for AI/ML updates and a new Risk Classification Module for non-IVD devices. This affects market access and post-market management for software manufacturers in India.

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Updated Aug 4, 2026