CDSCO Releases Draft Guidelines on Medical Device Software; MTaI Seeks AI/ML Evaluation Clarity

The 76-page draft outlines licensing, classification, applicable standards, quality management systems, and clinical evaluation requirements for software used in medical devices, including in vitro diagnostics (IVDs).

The Central Drugs Standard Control Organization (CDSCO) has released draft guidelines to regulate medical device software in India, aiming to align the framework with global standards.

The 76-page draft outlines licensing, classification, applicable standards, quality management systems, and clinical evaluation requirements for software used in medical devices, including in vitro diagnostics (IVDs).

Issuing a public notice, the Drugs Controller General of India (DCGI) stated, “...to align the requirements of Medical Device Software with globally harmonized practices, a draft of the Guidance Document on Medical Device Software is prepared to bring more clarity on the regulatory aspects.” The draft has been open for public comments for over 30 days.

Draft Guidance Details Scope, Standards, and Licensing

The guidance provides detailed instructions on the definition, scope, classification, technical documentation, and quality management systems applicable to medical device software. It also addresses clinical investigations and performance evaluations necessary for safety and effectiveness. The draft will be used to assess applications for manufacturing or importing medical device software in India.

Currently, the Medical Devices Rules, 2017, define technical and quality standards for Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD), forming the basis for regulatory assessments.

Industry Body Highlights Need for Clear AI/ML Protocols

The Medical Technology Association of India (MTaI), representing multinational companies, welcomed the draft but urged the CDSCO to clarify evaluation protocols for AI/ML-based devices. In a statement, MTaI noted, “While the guidance is a welcome step, the final document should provide greater clarity on clinical evaluation protocols and algorithm change management, particularly for AI/ML-based medical devices. Secondly, it should streamline compliance requirements for low-risk SaMDs to ensure regulatory proportionality and ease of implementation.”

Pavan Choudary, Chairman, MTaI, added, “This draft guidance reflects CDSCO’s commitment to keeping pace with the fast-evolving landscape of digital health technologies… and creates a foundation for safe, innovative, and globally competitive MedTech software solutions from India.”

The draft aims to formalize assessment processes for safety, performance, and quality of medical device software while incorporating public feedback before finalization.

Stay tuned for more such updates on Digital Health News