As software as a medical device (SaMD) gains significant traction in Singapore, the HSA has recently issued Guidelines on the Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software. This guideline, which references the International Medical Device Regulatory Forum’s (IMDRF) Framework for Software as a Medical Device (SaMD), can be used to determine the risk classification of SaMD products. The SaMD risk classification system will take into consideration the role in which the software plays in healthcare decision-making (diagnose, treat, etc.), the severity of the patient’s medical condition, and the existing risk classification guidelines for general medical devices.
In addition, the guideline also clarifies what qualifies Clinical Decision Support Software (CDSS) to be considered a medical device. Generally, CDSS products that have medical purposes (detection, prevention, treatment, etc. of various medical conditions) will be regulated as medical devices.