Therapeutic Goods Administration (TGA) Australia has published the finalised guidance document on examples of regulated and unregulated software in August 2021.
The guidance document presents examples that illustrate the boundaries between regulated and unregulated software. Software based medical devices are discussed in a separate document. Clarification on the requirements for regulated software based medical devices is important, and a recent implementation regarding this is the introduction of several exclusions and exemptions for specific types of software products.
There are two determinations that must be made to establish which software products are regulated as a medical device, and those which are not. Firstly, whether the software is intended to be used for a medical purpose, which will determine if a product will be evaluated by the health authority as a medical device. And secondly if the software meets the exclusion criteria.
One of the examples of an excluded software is a consumer health and wellness product not intended to manage serious conditions, such as a wearable that allows the wearer to track their heart rate for fitness. Medical image storage and retrieval software, or software that facilitates the communication or transfer of medical images between devices is another example.
For regulated software, the classification will be done according to the four-tier system for medical devices (Class I, IIa, IIb and III) and according to the level of harm that users and patients may be exposed to. As a comparison, a software that helps to monitor patients’ recovery from shingles using images of shingles rashes would be considered class I, whereas a software used for the analysis of a patient’s coronary angiogram and possible treatment plan is considered class III.
More details can be found in “Examples of regulated and unregulated software (excluded) software based medical devices, Version 1.2, August 2021”: https://www.tga.gov.au/resource/examples-regulated-and-unregulated-software-excluded-software-based-medical-devices