Blog
RSS FeedPosted 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 ...
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. ...
Posted by Michael Wonder on 15 Jan 2021
Regulation of software based medical devices
15 January 2021 - The TGA has updated its guidance on the regulation of software as a medical device. ...
Posted by Michael Wonder on 16 Aug 2020
Submissions received: scope of regulated software based medical devices
14 August 2020 - A total of 48 submissions were received in response to the Scope of Regulated Software based products ...
Posted by Michael Wonder on 16 Jul 2020
Actual and potential harm caused by medical software
16 July 2020 - TGA publishes a rapid literature review of safety and performance issues. ...
Posted by Michael Wonder on 02 Jul 2020
Cochlear calls for low risk health apps to be exempt from TGA register
3 July 2020 - Hearing implant giant Cochlear has called for some low risk health apps to be exempt from ...
Posted by Michael Wonder on 29 Apr 2020
Medicines Australia encourages 22,000 plus employees of the medicines industry to download the COVIDSafe app
29 April 2020 - As an economic and manufacturing leader in Australia, we pledge to encourage all our 22,000 + ...