New Delhi: The Medical Technology Association of India (MTaI) has welcomed the release of the Draft Guidance Document on Medical Device Software by the Central Drugs Standard Control Organization (CDSCO).
The association commended CDSCO for its proactive step in framing a comprehensive regulatory framework for Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD), including artificial intelligence (AI), machine learning (ML), and cloud-based medical applications.
“This draft guidance reflects CDSCO’s commitment to keeping pace with the fast-evolving landscape of digital health technologies. By providing clarity on definitions, classification, and quality management requirements, it creates a foundation for safe, innovative, and globally competitive MedTech software solutions from India,” said Mr. Pavan Choudary, Chairman, MTaI.
“We look forward to continuing our engagement with the regulator to ensure that the final framework remains innovation-friendly, risk-proportionate, and harmonized with global best practices,” he added.
MTaI also highlighted that while the guidance is a welcome step, the final version should:
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Streamline compliance requirements for low-risk SaMDs to ensure regulatory proportionality and ease of implementation.
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Align technical and quality standards with global best practices, including those developed by IMDRF, US FDA, and the EU MDR framework.
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Provide greater clarity on clinical evaluation protocols and algorithm change management, particularly for AI/ML-based medical devices.
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