14 May 2021
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
24 March 2021
In response to the COVID-19 pandemic, the TGA has expedited approvals for inclusion of COVID-19 tests in the Australian Register of Therapeutic Goods (ARTG). The TGA has commenced validation reviews of serology-based COVID-19 point-of-care tests included in the ARTG.
11 March 2021
In response to the COVID-19 pandemic, the TGA has expedited the approval (with conditions) of COVID-19 tests including tests intended for laboratory use and those intended for use by specified health professionals at the point of care.
19 February 2021
This is current advice relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections
13 January 2021
The TGA is undertaking a post-market review of all Point of Care and Laboratory tests included in the ARTG, which are intended to identify patients with COVID-19, to ensure they can detect the emerging SARS-CoV-2 genetic variants and remain accurate.
4 December 2020
Information for sponsors regarding the supply of COVID-19 tests, including advice for those sponsors new to therapeutic goods regulation in Australia
8 October 2020
How we test for COVID-19 in Australia
26 August 2020
Important information about the use of COVID-19 point-of-care tests.
26 August 2020
Dental board practitioners who are registered specialists in oral medicine have now been added to the list of specialist health practitioners who are permitted to initiate treatment using hydroxychloroquine
3 August 2020
Information on advertising of products related to COVID-19, GMP information for sponsors and manufacturers and access to coronavirus tests, medicines and vaccines, including medicine shortages