Industry bodies welcome CDSCO’s draft guidance on medical device software
New Delhi: Industry associations have lauded the Central Drugs Standard Control Organisation (CDSCO) for releasing a draft guidance document on medical device software, calling it a progressive move towards strengthening India’s regulatory framework in line with global standards.
Medical device software includes applications integrated within hardware medical devices (Software in a Medical Device or SiMD) as well as standalone digital tools designed for medical purposes (Software as a Medical Device or SaMD).
In its notice issued Tuesday, the CDSCO said the draft guidance aims to enhance regulatory clarity and align India’s requirements with international best practices.
“This guidance document outlines the scope, definitions, classifications, standards, and quality management requirements for medical device software. Applicants may refer to it while applying for manufacturing or import licences for such products,” said Dr. Rajeev Singh Raghuvanshi, Drug Controller General of India (DCGI).
Medical device software plays a vital role in diagnostics, treatment, and patient monitoring, and is therefore subject to stringent safety and performance regulations.
Rajiv Nath, Forum Coordinator of the Association of Indian Medical Device Industry (AiMeD), hailed the draft as a “timely and progressive step” that supports both innovation and patient safety.
“With digital health solutions becoming central to modern healthcare, a robust regulatory framework is essential. We welcome the CDSCO’s move to update and clarify the requirements for Software as a Medical Device,” Nath said, proposing a stakeholder webinar to gather feedback and align India’s framework with the International Medical Device Regulators Forum (IMDRF).
The Medical Technology Association of India (MTaI) also appreciated the CDSCO’s initiative, commending the comprehensive approach covering SiMD, SaMD, and emerging technologies such as artificial intelligence (AI), machine learning (ML), and cloud-based medical applications.
“This draft guidance underscores CDSCO’s commitment to keeping pace with rapid digital health advancements. By clarifying definitions, classifications, and quality management norms, it sets the foundation for safe, innovative, and globally competitive MedTech software solutions from India,” said Pavan Choudary, Chairman of MTaI.
MTaI further recommended simplifying compliance for low-risk SaMDs, aligning quality standards with global norms, and providing clearer guidance on clinical evaluation and algorithm management for AI/ML-based devices.
