5 February 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.
5 February 2021
The Doherty Institute has completed its validation of fifteen serology-based point of care tests as part of a TGA post market review. The TGA has requested the sponsors of these devices to provide further information on the clinical studies undertaken by the manufacturer to support the performance...
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 on the three types of COVID-19 tests (nucleic acid/PCR, Rapid antigen and serology antibody tests), including test performance.
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.
28 August 2020
The TGA has issued three infringement notices for $39,960 to Melbourne-based company Yarra Valley Cleaning Co for the alleged unlawful advertising of a disinfectant product in relation to COVID-19.
26 August 2020
Important information about the use of COVID-19 point-of-care tests.
6 August 2020
The TGA has issued two infringement notices, each for $12,600, to Melbourne-based companies Australian Beauty Group and VeraTemp for the alleged unlawful importation and advertising of medical devices in relation to COVID-19.