CDSCO Issues Draft Guidance on Medical Device Software Inviting Stakeholder Comments

CDSCO Issues Draft Guidance on Medical Device Software Inviting Stakeholder Comments

The Central Drugs Standard Control Organisation (CDSCO) along with a circular dated 21st Oct, 2025 released the “Guidance Document on Medical Device Software”. Regulated by the Medical Devices Rules (MDR), 2017, the document aims to bring clarity to the regulatory requirements for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) in India, aligning them with international standards and best practices.

Objective of the Draft Guidance

According to the Drugs Controller General of India (DCGI), the guidance defines the scope, classification, and quality management requirements for medical device software. It will help Indian manufacturers and importers while applying for licences to manufacture or import medical device software for sale and distribution.

“This draft provides clarity on technical documentation, safety standards, and quality management systems applicable to software-based medical devices. Stakeholders may refer to it while submitting applications for manufacturing or import licences,” said the DCGI. 

Submission & Compliance Process

Applications for a Test Licence for Medical Device Software must be submitted through the National Single Window System (NSWS) portal, whereas all other applications — including registration, permission, or import licence — should be filed via the Medical Devices (MD) Online Portal.

The guidance covers both Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD), including AI-based, ML-based, and cloud-enabled healthcare software. It further defines critical terms such as active medical device, clinical investigation, clinical performance evaluation, predicate device, and intended use under MDR 2017.

Not a New Regulation, But a Framework for Clarity

The CDSCO clarified that this document should not be considered as a new regulatory control, but as a framework to interpret existing provisions more clearly. The goal is to streamline compliance, ensure patient safety, and promote innovation within the Indian digital health ecosystem.

Recommendations for the Final Framework

Being a draft inviting comments from stakeholders. industry leaders have requested the regulator to:

• Simplify compliance for low-risk SaMDs, ensuring risk-proportionate regulation.
   
• Align standards with IMDRF, US FDA, and EU MDR frameworks.
   
• Provide clear clinical evaluation protocols for AI/ML-based medical software.
   
• Define algorithm change management guidelines to maintain transparency and safety.

Click here to know more and access the official guidance document

Note:
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