Australia TGA Publishes Frequently Asked Questions on Software-Based Medical Devices

The Therapeutic Goods Administration (TGA) Australia has published a set of frequently asked questions (FAQs) on software-based medical devices in December 2021. 

Software used for health or medical purposes need to be registered in Australia and included in the Australian Register of Therapeutic Goods (ARTG). The FAQs will assist in making decisions for certain questions, such as if the software is considered a software-based medical device and to pinpoint the purpose of the software. 

For example, if the software-based medical device has several functions, classification is key and there may be more than one rule to consider. The software will be categorised at the highest classification, depending on the function of the software. Therefore, if the software has two functions and the classifications are Class I and Class III (for example), the software will be considered a Class III medical device. 

More details can be found in “Software-based medical devices FAQs, December 2021”:  

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