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Health Sciences Authority
Regulatory Updates

Update for Guidelines on Risk Classification of SaMD and Qualification of Clinical Decision Support Software (CDSS)

Audiences

Industry member

Product type

Medical devices

21 July 2025

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Dear Medical Device Stakeholders

The Medical Devices Cluster (MDC) has updated Guidelines on Risk Classification of SaMD and Qualification of Clinical Decision Support Software (CDSS)

Key Updates

  • Change in document title to "Guidelines on Risk Classification of SaMD and Qualification of Clinical Decision Support Software (CDSS)" to improve online searchability

  • Replace "Standalone Medical Mobile Applications" term to "SaMD" for better international alignment

  • Provide better clarity on criterion when SaMD will be classified as Class B if its functionality falls under rule 10(i) of GN-13

  • Include additional criterion (i.e. Output/recommendations of CDSS is solely based on established clinical guidelines) to determine whether a CDSS is considered a non-MD

The finalised version can be accessed here and will be effective 21 July 2025:

Thank you.
MEDICAL DEVICES CLUSTER
HEALTH SCIENCES AUTHORITY
SINGAPORE