6 October 2021
The TGA is undertaking a post-market review of all face masks included in the Australian Register of Therapeutic Goods to ensure the quality and effectiveness of face masks.
30 September 2021
The TGA is undertaking a post-market review of face masks included in the ARTG. This page lists all face masks that have been cancelled from the ARTG during the review.
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.
18 August 2021
Information about a TGA post-market review of face masks, including guidance for suppliers and users of face masks.
9 June 2021
Action in relation to non-compliant face masks will be published on the TGA web site
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.