14 October 2021
Update to TGA's conditions and advertising requirements for COVID-19 rapid point-of-care tests.
28 September 2021
Updated to reflect changes to allow self-testing and updated conditions.
20 September 2021
Answers to frequently asked questions in relation to rapid antigen tests.
8 September 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.
7 September 2021
Guidance and checklist for businesses to understand the requirements for safe implementation of COVID-19 rapid antigen point-of-care testing.
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.
30 September 2020
The TGA has issued an infringement notice totalling $13,320 to Sydney-based company Hepworth Industrial Wear for the alleged unlawful importation of surgical face masks in relation to COVID-19.
3 September 2020
The TGA has initiated proceedings in the Federal Court of Australia in response to alleged unlawful advertising of hyperbaric oxygen therapy chambers by Oxymed Australia and its sole director, Mr Malcolm Hooper.
1 September 2020
The TGA has issued two infringement notices totalling $26,640 to Sydney-based company Markson Sparks for the alleged unlawful advertising of a medical device in relation to COVID-19.