Posted by Michael Wonder on 12 Aug 2021
Reclassification of software based medical devices
12 August 2021 - Recent changes to regulation of software based medical devices came into effect in early 2021, which result in change of classification level for certain devices.
All new applications for inclusion of software based medical devices in the Australian Register of Therapeutic Goods must meet these new classification rules.
For software that is already on the Australian Register of Therapeutic Goods, there is a transition period.
