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regulatory guidance

18 March 2021
Guidance on the TGA's expectations concerning clinical performance requirements and risk mitigations for in vitro diagnostic medical devices intended to be used as self-tests for hepatitis B virus (HBV) and hepatitis C virus (HCV).
18 March 2021
Guidance on the TGA's expectations concerning clinical performance requirements and risk mitigation for in vitro diagnostic medical devices intended to be used as self-tests for seasonal influenza.
11 October 2021
This guidance document provides information about when and how clinical decision support software is regulated in Australia by the TGA.
12 March 2021
Guidance for procurement areas in hospitals, aged care residential facilities and other facilities
27 July 2021
The purpose of this document is to guide developers and users of software to decide which software and apps are medical devices
11 October 2021
Guidance presenting examples that illustrate the boundaries between regulated and unregulated software.
24 February 2021
This guidance summarises the regulatory approach of the TGA for software based medical devices
9 August 2021

This guidance provides a summary of changes to the regulation of software based medical devices (including software as a medical device)

22 December 2020
This guidance helps sponsors and manufacturers of therapeutic goods to understand and use the Poisons Standard to determine if any restrictions apply to their product

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