Medical Device Software Rules: Industry Welcomes CDSCO's New Draft Guidance

Medical device software is software that is either integrated into a hardware medical device (Software in a Medical Device or SiMD) or operates independently as a standalone application for medical purposes (Software as a Medical Device or SaMD).

The CDSCO, in an official notice on Tuesday, shared the draft of the guidance document to bring more clarity on regulatory aspects of medical device software and to align the requirements with best global practices.

“This guidance document provides scope, definition, classification, standards, requirements of technical documents, and Quality Management system applicable for Medical Device Software. The applicants may refer to the documents during submission of application for grant of licence to manufacture or import Medical Device Software for sale and distribution in the country,” Rajeev Singh Raghuvanshi, the Drug Controller General of India (DCGI), the head of CDSCO, in the notice.

Medical device software is used for diagnostics, treatment, and patient monitoring, and is subject to strict regulatory standards to ensure patient safety and effectiveness.

“We welcome the updated revised Government’s draft guidance note on Software as a Medical Device (SaMD) as a timely and progressive step towards strengthening India’s regulatory ecosystem. With digital health solutions playing an increasingly critical role in patient care, it is essential that our regulatory framework ensures both patient safety and innovation,” Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD)

Nath also proposed hosting a webinar to educate stakeholders and invite feedback, to align India’s framework with the International Medical Device Regulators Forum (IMDRF) and other global best practices.

“This will ensure patient safety while enabling Indian innovations to thrive internationally," he added.

The Medical Technology Association of India (MTaI) also welcomed the draft guidance document and commended CDSCO for its proactive step in framing a comprehensive regulatory framework for SiMD and SaMD, including artificial intelligence (AI),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“This draft guidance reflects CDSCO’s commitment to keeping pace with the fast-evolving landscape of digital health technologies.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 Pavan Choudary, Chairman, MTaI.

MTaI also suggested streamlining compliance requirements for low-risk SaMDs to ensure regulatory proportionality and ease of implementation; aligning technical and quality standards with global best practices; and providing greater clarity on clinical evaluation protocols and algorithm change management, particularly for AI/ML-based medical devices.

- IANS