Dive Brief:

• Australia’s Therapeutic Goods Administration has released guidance on the regulation of software as a medical device (SaMD), setting out its current position on software products that fit its definition of a medical device.

• The advice is likely to change in the near future. Notably, TGA is concerned that its current regulations underestimate the risks posed by many SaMDs and plans to hold a consultation about changes to address this perceived problem.

• The guidance defines SaMDs as software that meets the existing definition of a medical device, for example because it is involved in the diagnosis, prevention, monitoring or treatment of disease.

Dive Insight:

TGA signaled that it, like many of its regulatory peers, was paying more attention to the role of software in healthcare when it commissioned a research report into SaMDs in August. Australia’s Commonwealth Scientific and Industrial Research Organisation, the group tasked with the research, completed the project earlier this year but TGA has yet to share the findings.

Now, TGA has hinted at some of the possible outcomes of the research in guidance that provides a broad overview of SaMDs and its plans in the area.

Through the examples, TGA defines the borders of the SaMD space. Mobile apps intended to support healthy lifestyles are not classed as SaMDs, nor is software that is integral to a medical device. Apps that control medical devices, by Bluetooth or other means, are categorized as SaMDs, though. The borders of the SaMD space sketched out by TGA overlap with those adopted by other regulators.

TGA’s definition looks to be set but there remains considerable scope for it to change how it regulates products that fall within the definition. In the guidance, TGA notes that its current risk-based approach to medical device regulation fails to capture the dangers posed by SaMDs.

The rules permit the classification of SaMDs as everything from low to high-risk devices. However, TGA thinks "many SaMD products are classified as low risk even though the potential risk for users may be higher." The agency plans to propose regulations intended to ensure it applies the right level of scrutiny and oversight to all SaMDs.

While TGA is yet to share details of the regulations, its comments suggest the changes will lead to many SaMDs becoming subject to more stringent rules. TGA plans to release the regulations for consultation soon.