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.
25 August 2021
COVID-19 tests must be done under the direction of a health professional. The advertising and sale of home tests is prohibited.
31 January 2021
What you need to know before you seek to import personal protective equipment (PPE) into Australia during the COVID-19 pandemic.
28 January 2021
Guidance to help determine when a face mask is a medical device and therefore must be included in the Australian Register of Therapeutic Goods (ARTG).
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.
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.