Overview of the Draft Guidance
India’s MedTech industry has largely welcomed the Central Drugs Standard Control Organisation (CDSCO) draft guidance on medical device software, issued on October 21, 2025, describing it as a progressive step toward global harmonization and digital health innovation.
The 76-page draft provides comprehensive direction on the scope, classification, and quality requirements for medical device software. It includes guidelines for:
- AI/ML-based systems
- Cloud and networked applications
- In vitro diagnostic (IVD) software
- Post-market quality systems
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The draft applies to all software falling under the definition of a “medical device” as per Rule 8 of MDR-2017, covering two primary categories:
- Software in a Medical Device (SiMD)
- Software as a Medical Device (SaMD)
According to the CDSCO, the draft is intended to reflect current regulatory practices under MDR-2017 and should not be viewed as introducing new regulatory controls. Instead, it aims to help manufacturers and importers of medical and IVD software ensure compliance while submitting applications for licences or permissions.
Industry Applauds CDSCO’s Progressive Move
Major industry associations, including the Medical Technology Association of India (MTaI) and the Association of Indian Medical Device Industry (AiMeD), have praised the CDSCO’s initiative for providing clearer definitions, classification criteria, and quality management frameworks for SaMD and SiMD.
MTaI Chair Pavan Choudary called the draft “a foundation for safe, innovative, and globally competitive MedTech software solutions,” while emphasizing the need for further clarity on clinical validation and algorithm change management for AI-integrated devices.
AiMeD Forum Coordinator Rajiv Nath described the draft as “a timely and progressive step,” recommending that the CDSCO conduct stakeholder workshops to harmonize India’s framework with International Medical Device Regulators Forum (IMDRF) guidelines. He stated that such alignment would enhance patient safety and global recognition of Indian medical software innovations.
Call for Clarity on AI/ML and Risk-Based Regulation
While welcoming the draft, several stakeholders have requested greater regulatory clarity in areas such as:
- Oversight of AI/ML-driven medical devices
- Clinical evaluation procedures
- Algorithmic update management
The industry has also called for a risk-based compliance approach, suggesting streamlined procedures for low-risk SaMDs to encourage startups and MSMEs, while maintaining appropriate oversight for high-risk clinical applications.
A Step Toward Global Regulatory Parity
The draft guidance signifies a key milestone in CDSCO’s efforts to modernize India’s MedTech regulatory ecosystem. By aligning local frameworks with international standards, India moves closer to achieving global regulatory parity in medical software governance — fostering an environment that supports innovation, safety, and global competitiveness.
Role of Operon Strategist
As India’s regulatory environment evolves to accommodate digital health innovations, Operon Strategist plays a crucial role in guiding manufacturers and software developers through compliance with MDR-2017.
Operon Strategist assists companies in:
- Classifying software as SiMD or SaMD under CDSCO guidelines
- Preparing regulatory submissions and documentation for licensing
- Implementing ISO 13485-compliant QMS for software-based devices
- Ensuring alignment with IMDRF and global best practices
With expertise in medical device consulting and regulatory strategy, Operon Strategist empowers MedTech innovators to achieve faster market access, maintain regulatory compliance, and build trust in AI/ML-integrated healthcare solutions.
