On July 21, 2025, Singapore’s Health Sciences Authority (HSA) published updated guidance for the risk classification of Software as a Medical Device (SaMD) and qualification of Clinical Decision Support Software (CDSS). The HSA wants to achieve three goals with the updated guidance: 1) Better alignment with international standards; 2) Improved clarity on regulatory expectations; and 3) Better online searchability through clearer terminology. Some of the key revisions made to the document include the new title “Guidelines on Risk Classification of SaMD and Qualification of Clinical Decision Support Software (CDSS)” to make online searchability easier. The HSA also replaced the term “Standalone Medical Mobile Applications” with “SaMD” to align with the global use of terminology.
In addition, the HSA assigned a Class B risk classification to SaMDs that are designed to measure, monitor, or analyze physiological processes (e.g., heart rate or blood pressure) or structural images of anatomy (e.g., X-rays and ultrasounds) for clinical management purposes. This reclassification harmonizes the SaMD risk classification with HSA’s existing framework for general medical devices. The HSA also provided additional clarity around when and why CDSS would not be classified as a medical device. For example, if a CDSS product only generates recommendations based on established clinical guidelines, or if the product only displays medical information about a patient, it will not be considered a medical device.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.