The Health Sciences Authority (HSA) Singapore has published the first version of the guidelines on the determination of risk classification of standalone medical mobile applications that are medical devices, which is also referred to as SaMD, as well as information on the qualification of clinical decision support software (CDSS) in April 2022.
The risk classification framework for SaMD will factor in information provided in the application, the patient’s condition, and the rules in the GN-13 Guidance on Risk Classification.
As for the CDSS, they are standalone software but not all considered to be medical devices. The guideline provides some insight on this and will help in deciding if a CDSS is a medical device, as well as the risk classification.
More details can be found in “Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS): Medical Devices Cluster, Revision 1, April 2022”: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gudiance-documents-for-medical-devices/guidelines-risk-classification-samd-cdss-(2022-apr)-pub68164581f0d548c29794b7c61b3c8dfc.pdf