CDSCO Unveils Final Medical Device Software Guidance, Bringing Greater Regulatory Clarity for Digital Health Innovators
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It is intended to help manufacturers, importers, innovators and researchers understand the regulatory framework, documentation requirements, quality management expectations and approval process for MDSW, including IVD Medical Device Software, under the Medical Devices Rules, 2017.
The Central Drugs Standard Control Organisation (CDSCO) has released its final guidance document on Medical Device Software (MDSW), providing clearer regulatory expectations for software-based medical technologies while strengthening quality, safety and compliance standards under the Medical Devices Rules, 2017.
While the Medical Devices Rules, 2017 already govern software that qualifies as a medical device, the rapid evolution of AI, cloud computing and connected health technologies has created a need for more detailed guidance for manufacturers, importers and developers.
The CDSCO has now issued the final guidance document after revising the draft released on October 21, 2025, incorporating stakeholder feedback and expert consultations.
The document is intended to help manufacturers, importers, innovators and researchers understand the regulatory framework, documentation requirements, quality management expectations and approval process for Medical Device Software, including in-vitro diagnostic (IVD) Medical Device Software, under the Medical Devices Rules, 2017.
"It outlines the regulatory framework, classification principles, applicable safety and performance requirements, documentation expectations, quality management considerations, and post-market obligations to facilitate compliance with the applicable regulatory requirements," said Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India) while releasing the final document.
"It is intended to promote a consistent understanding and implementation of regulatory requirements while supporting innovation, patient safety, product quality, and timely market access for Medical Device Software," he added.
The guidance also explains which software falls within the scope of regulation. It covers software that performs medical functions independently or works alongside connected medical devices, including AI-enabled digital platforms that monitor chronic diseases, analyse patient data and support clinical decision-making.
At the same time, software used solely for general wellness, fitness tracking or enterprise resource planning (ERP) functions is excluded from the Medical Device Software definition.
Compared with the earlier draft, the final guidance expands expectations around quality management systems, software lifecycle management, cybersecurity, risk management and post-market monitoring.
Manufacturers are expected to establish documented quality systems, maintain Software Bills of Materials (SBOM), continuously monitor device performance and evaluate products across different healthcare settings to ensure safe and effective use within India's healthcare ecosystem.
The document also emphasises interoperability, consent-based health data access, secure information exchange, privacy protection and digital traceability.
The guidance further provides more detailed requirements for technical documentation, usability validation, cybersecurity risk assessment, AI bias evaluation and test licence applications.
It recommends that software validation considers Indian clinical workflows, healthcare infrastructure and variations in user expertise, reflecting the practical conditions under which Medical Device Software is deployed across the country.
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