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Medical devices/IVDs

18 March 2021
Guidance on TGA's expectations concerning clinical performance requirements and risk mitigations for in vitro diagnostic medical devices intended to be used as self-tests for chlamydia, gonorrhoea and syphilis.
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.
9 March 2021
The IMDRF working group is seeking comments from interested parties on the proposed guidance document. Closing date: 19 April 2021
26 February 2021
TGA is seeking comments on whether the Australian medical device regulatory framework should be aligned to the EU framework for medical devices containing nanomaterials. Closing date: 9 April 2021
23 August 2021
Frequently asked questions to further clarify the new regulatory framework for personalised medical devices
19 February 2021
Overview of the new framework including regulatory terminology and worked examples
19 February 2021
Overview of the new framework including regulatory concepts and worked examples for the dental industry
11 October 2021
This guidance document provides information about when and how clinical decision support software is regulated in Australia by the TGA.

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