Jul 21, 2021

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.

Guidance draws on IMDRF framework for SaMD

The risk classification framework is based on the framework for Software as a Medical Device (SaMD) (download link) drawn up by the International Medical Device Regulators Forum (IMDRF). The risk classification table derived from this framework applies to non-IVD standalone mobile applications only. IVD standalone mobile applications must reference the Guidance on the Risk Classification of IVD Medical Devices (GN-14) for their classification.

The draft guide also provides a flowchart for identifying whether a CDSS application is regulated as a medical device. Risk classification for a CDSS application identified to be a medical device can be determined based on the risk classification table in the guide.

The HSA will be accepting feedback on this draft guidance until August 19, 2021.​

More medical device regulatory resources for Singapore from Emergo by UL:


  • Timothy Herr