Australia: Software-Based Medical Devices FAQs

In December of 2021, the Therapeutic Goods Administration (TGA) of Australia released a publication containing the frequently asked questions (FAQ) regarding software based medical devices. According to the TGA, software based medical devices are medical devices that incorporate software or are software, including software as a medical device (SaMD), or software that relies on particular hardware to function as intended. All software, including mobile apps, is a medical device as long as it fits under the definition of a medical device under section 41BD of the Therapeutic Goods Act 1989, unless otherwise excluded. This means it has to be registered with the TGA and included in the Australian Register of Therapeutic Goods (ARTG). As such, it is the manufacturer’s job to determine if their product must be included in the ARTG prior to supply in Australia, is exempt, or is pertinent to exclusion.

The TGA requests that individuals, companies and manufacturers planning to supply their software in Australia to read the FAQs as they go very in-depth on what is required to operate legally in Australia.

Device classification As of 25 February 2021, the TGA classifies software based medical devices under four categories. These are medical devices that:

• Provides a diagnosis or screen for a disease or condition

• Monitor the state or progression of a disease or condition, or the parameters of a person with a disease or condition

• Specify or recommend a treatment or intervention

• Provides therapy through a provision of information

Note that software-based medical devices to be reclassified due to the regulatory changes are allowed a transition period of until 1 November 2024. If the device is already included in ARTG, it can continue to be supplied in Australia while being applied to be included in the ARTG under the new classification. Cases to consider Also note that there is a difference between exclusion and exemption. Exclusion means the device is not subject to any TGA regulation, while exemption means that while registration is not required, TGA still retains some oversight for advertising, adverse events and notification. Exempted devices are usually clinical decision support systems.

Types of excluded devices include:

• Consumer health products – self management of diseases that are not serious

• Enabling technology – telehealth or dispensing

• Digitization – of paper based or other published rules or data, calculators, EMRs

• Population based analytics – data analytics not meant for individual use

• Laboratory Information Management System – devices that automate workflow

Sources: Software-Based Medical Devices FAQs Contact us at info@arqon.com for more info