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

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 CDSCO guidance for Medical Device Software?
- How does the 2026 guidance impact manufacturers of SaMD and SiMD for the Indian market?
- What specific usability validation is now required for Indian clinical workflows?
- How must risk management files be updated to address cybersecurity and AI bias?
- Why is a Software Bill of Materials (SBOM) now mandatory for MDSW in India?
- What are the first steps your team should take to conduct a gap analysis against the new rules?
- How can you prepare for India-specific validation studies?

Sources:
- https://www.pharmabiz.com/NewsDetails.aspx?aid=171120&name=CDSCO-releases-final-guidance-document-on-Medical-Device-Software

How Pure Global can help:
Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. Our experts develop efficient regulatory strategies and use advanced AI to compile and submit technical dossiers for markets like India, ensuring compliance with new requirements like the CDSCO MDSW guidance. We act as your local representative in over 30 countries, manage post-market surveillance, and monitor regulatory changes to maintain your market presence. To access global markets faster, contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

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