This article goes into detail on standalone software (i.e. software that is not attached to any physical medical device) and how it is increasingly becoming a means by which conditions are treated, diagnosed, or monitored.
Because an app of this nature could have an intended medical purpose, it may thus constitute a medical device under the Therapeutic Goods Act 1989 (Cth) and must be registered on the on Australian Register of Therapeutic Goods before being suppled in Australia.
Authors: Christine Ecob, Partner, and Stanley Yu, Senior Associate, Johnson, Winter & Slattery
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