Posted by Michael Wonder on 19 Feb 2021
Clinical decision support software
18 February 2021 - From 25 February 2021, the way that software-based medical devices are regulated in Australia will change.
Clinical decision support software (CDSS) that meets the definition of a medical device must be included in the Australian Register of Therapeutic Goods unless otherwise exempt.
Under the changes, an exemption has been introduced for some CDSS that is a medical device.
