Singapore – Singapore HSA holds consultation on SaMD classification draft guidance

Singapore’s Health Sciences Authority (HSA) has initiated a public consultation on the draft Regulatory Guidelines for Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS). The draft outlines the risk classification framework for standalone medical mobile applications that are considered medical devices for regulatory purposes (software as a medical device, or SaMD) and provides clarity on the criteria for clinical decision support software (CDSS) qualifying as a medical device…