TGA is proposing to treat software as a medical device in its own right. Presently it’s only regulated as part of another medical device used to treat patients if it could cause harm to patients. The new reforms would treat the software as a medical device directly if it’s used by medical practitioners to diagnose patient conditions (different levels for critical outcomes diagnosis or just screening). The new proposed regulations are based on
International Medical Devices Regulators Forum (IMDRF) guidelines.
See the following Source for further details.