Update for Guidelines on Risk Classification of SaMD and Qualification of Clinical Decision Support Software (CDSS)
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:
- Guidelines on Risk Classification of SaMD and Qualification of Clinical Decision Support Software (CDSS)
Thank you.
MEDICAL DEVICES CLUSTER
HEALTH SCIENCES AUTHORITY
SINGAPORE
Industry member, Medical devices
Published:
Regulatory Updates