16 June 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.
9 June 2021
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.
9 June 2021
Action in relation to non-compliant face masks will be published on the TGA web site
27 May 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.
14 May 2021
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
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.
12 March 2021
In response to the COVID-19 pandemic, the TGA has received a significant number of thermometer applications. This guidance assists thermometer sponsors and manufacturers to meet their regulatory obligations.
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.
9 March 2021
Due to the unprecedented pressures COVID-19 has placed on the pharmaceutical industry, sponsors of listed medicines and registered over-the-counter (OTC) and complementary medicines (RCM) are eligible to request consent not to comply with TGO 92 labelling requirements for a limited time.
19 February 2021
This is current advice relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections