CDSCO Releases Final Guidance Document on Medical Device Software
The Central Drugs Standard Control Organisation (CDSCO) has released the final Guidance Document on Medical Device Software (MDSW), providing a clear regulatory framework for manufacturers, importers, innovators, and researchers seeking approvals under the Medical Devices Rules (MDR), 2017.
The guidance has been revised after considering stakeholder feedback on the draft published in October 2025.
It aims to align India’s regulatory requirements with globally harmonized practices while supporting innovation, ensuring patient safety, and improving the quality and compliance of medical device software.
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Key Highlights of the Final Guidance
- Comprehensive Regulatory Framework: The guidance outlines the regulatory requirements for Medical Device Software (MDSW), including software intended for medical purposes and IVD applications. It covers product classification, regulatory submissions, technical documentation, quality management, and post-market obligations.
- Expanded Scope for Digital Health Technologies: The final guidance includes software using Artificial Intelligence (AI), Internet of Things (IoT), digital therapeutics, and advanced data analytics when intended for medical purposes. However, general wellness, fitness, and ERP software remain outside the scope of MDSW regulations.
- Stronger Quality & Cybersecurity Requirements: Manufacturers are expected to implement a robust Quality Management System (QMS) based on standards such as IEC 62304, ISO 14971, and IEC 82304-1. The guidance also emphasizes cybersecurity, Software Bill of Materials (SBOM), continuous performance monitoring, and secure interoperability within India’s digital health ecosystem.
- Enhanced Technical Documentation: The guidance introduces more detailed requirements for usability validation, risk management, AI bias assessment, cybersecurity documentation, and clinical performance evaluation, ensuring that software is safe, effective, and suitable for real-world healthcare environments.
The Drugs Controller General (India) has advised all stakeholders to refer to the final guidance while submitting applications for regulatory approval under the Medical Devices Rules, 2017.
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