Singapore HSA Medical Devices Cluster has updated Guidelines on Risk Classification of Software as a
Medical Device (SaMD) and Qualification of Clinical Decision Support Software (CDSS).
Key Updates are as following:
• 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 updated guideline can be accessed at the following link: