India's 2026 CDSCO Guidance on Medical Device Software (MDSW): Key Compliance Steps

Medical Device Global Market Access · Jul 25, 2026 · 5m

This episode covers India's CDSCO final guidance for Medical Device Software (MDSW), released on July 23, 2026. We discuss the key compliance requirements for manufacturers and importers under the Medical Devices Rules, 2017, including new expectations for technical documentation, usability validation for Indian clinical workflows, risk management for cybersecurity and AI bias, and the mandatory Software Bill of Materials (SBOM). Learn the actionable steps your regulatory and quality teams need to take to ensure market access in India. Key Questions: - What are the key requirements in the new…