Singapore HSA 2025 SaMD & CDSS Guidelines Update

Singapore’s Health Sciences Authority (HSA) has released an updated version of the “Guidelines on Risk Classification of SaMD and Qualification of Clinical Decision Support Software (CDSS)”, introducing key improvements to align with international terminology and provide clearer classification criteria.

Published in July 2025, this update is essential for manufacturers and developers of Software as a Medical Device (SaMD) and Clinical Decision Support Software (CDSS) seeking compliance under Singapore’s Health Products Act.

View the official HSA update  

Key Updates in the 2025 HSA Guidance

• Title change: The document title has been updated to “Guidelines on Risk Classification of SaMD and Qualification of CDSS” to improve online search visibility.

• Terminology update: Replaces “Standalone Medical Mobile Applications” with the globally recognized term SaMD to align with IMDRF and FDA conventions.

• Clarified Class B conditions: Adds clarity to when SaMD will be classified as Class B, particularly under Rule 10(i) of GN-13, where functionality supports critical clinical decision-making.

• CDSS qualification criterion: Introduces a new criterion specifying that CDSS software is not regulated as a medical device if its recommendations are solely based on established clinical guidelines and do not incorporate adaptive logic or AI.

Impact for Developers and Manufacturers

This update provides greater regulatory certainty and better aligns Singapore’s classification framework with global practices. It helps software developers determine:

• If their product qualifies as SaMD

• The appropriate risk class (A–D)

• Whether a CDSS is regulated under the Health Products Act

It is particularly relevant for companies developing AI-powered decision support systems or mobile-based diagnostics.

What You Should Do

To ensure compliance with the updated framework, companies should:

1. Download and review the revised guidance

2. Reassess current product classifications, especially those using mobile platforms or AI features

3. Consult HSA early in the product development lifecycle if classification is unclear

Understanding these changes early helps reduce delays in regulatory submission and market access.

Related Resources

• GN-13 Risk Classification Rules (PDF)

• Pure Global: Medical Device Market in Singapore

• Pure Global: HSA Medical Device Regulations

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