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Singapore: HSA Releases Updated SaMD and CDSS Guidelines (effective from 21 July 2025)

As the digital health landscape continues to evolve rapidly, the Health Sciences Authority (HSA) released the Revision 2 (R2) of its guidelines with an updated title, “Guidelines on Risk Classification of Software as a Medical Device (SaMD) and Qualification of Clinical Decision Support Software (CDSS)”.  The changes include both SaMD and CDSS explicitly to aid the online searches and provide better reflections on the document’s comprehensive scope.


This update reflects HSA’s ongoing efforts to align with international standards and provide greater clarity for manufacturers, regulators, and healthcare providers navigating the complexities of software in medical settings.


What’s New in Revision 2?

The updated guidelines introduce both terminological refinements and classification enhancements aiming at improving regulatory clarity, international alignment, and practical implementation for MedTech stakeholders.

  • International Alignment: “SaMD” Replaces “Standalone Medical Mobile Applications”

    • The outdated term has been replaced with Software as a Medical Device (SaMD) to reflect globally accepted terminology and practices

  • Risk Classification Table: Clearer Criteria for Class B SaMD

    • Additional clarification is provided for SaMD falling under Rule 10(i) of GN-13:

      • SaMD that analyses or monitors vital physiological processes, for example, heart rate, blood pressure, or anatomical structure images such as X-rays, to drive clinical management is now clearly classified as Class B

  • Expanded Criteria for Non-Medical Device CDSS

    • A major addition in R2 is the inclusion of a new criterion to qualify software as a Non-Medical Device (Non-MD):

      • If the output or recommendation of the CDSS is solely based on established clinical guidelines, such as the WHO, it is not regulated as a medical device

      • This change brings significant clarity for manufacturers of decision-support tools that do not generate new medical insights but rely on verified medical standards

 

Implications for Stakeholders

For MedTech innovators, healthcare software developers, and regulatory professionals, these updates have direct implications:

  • Streamlined Regulatory Strategy

Helps companies determine early on whether their software will be regulated as a medical device-saving time, cost, and effort in compliance planning.

  • Risk Classification Transparency

Enhanced classification examples and clearer application of the GN-13 rules empower teams to accurately assess product risk levels

  • Global Harmonization

The updates align Singapore’s regulatory approach with international standards, such as IMDRF, FDA, and TGA, easing multi-market product development.


Examples of Software Classifications

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Conclusion

The refinement of the SaMD and CDSS guidelines marks a progressive step for digital health regulation in Singapore. By balancing innovation with patient safety, HSA continues to provide a structured yet adaptable framework for next-generation medical software.


For companies designing clinical support tools or diagnostic applications, understanding this updated framework is crucial to ensure proper risk classification, faster market entry, and regulatory peace of mind.

 

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