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Medical devices/IVDs

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)

8 September 2021

New consumer information relating to face masks

17 March 2022

The post-market review of COVID-19 test kits now includes the Omicron variant.

29 November 2021
A submission summary on the Australian Regulations definition of CCS consultation is available on our consultation hub
2 December 2020
Guidelines is to assist applicants seeking a conformity assessment (priority applicant) determination or a medical devices (priority applicant) determination
31 January 2021
Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 ceases on 31 January 2021.
10 August 2021
Guidance to assist manufacturers in choosing appropriate standards and to set out the TGA's expectations for performance testing
2 March 2022
Information on TGA laboratory testing of face masks and respirators
28 January 2021
Guidance relating to evidence requirements for applications for inclusion in the ARTG


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