14 January 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.
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 January 2021
What you need to know before you seek to import personal protective equipment (PPE) into Australia during the COVID-19 pandemic.
24 December 2020
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.
24 December 2020
Information about a TGA post-market review of face masks, including guidance for suppliers and users of face masks.
18 December 2020
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.
2 December 2020
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.
20 November 2020
A list of ventilators that meet minimum requirements and are permitted to be supplied under the COVID-19 Emergency Exemption.
6 November 2020
Action in relation to non-compliant face masks will be published on the TGA web site
19 October 2020
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...