22 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.
10 June 2021
The TGA has issued two infringement notices totalling $26,640 to Sydney company Aidacare Pty Ltd (Aidacare).
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
3 June 2021
The TGA has issued two infringement notices to Perth-based company V P & Associates Pty Ltd (V P & Associates), for alleged unlawful advertising of a medical device in relation to SARS-CoV-2 Human Coronavirus.
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.
21 May 2021
Guidance to assist manufacturers in choosing appropriate standards and to set out the TGA's expectations for performance testing of respirators, surgical respirators and medical/surgical facemasks, before inclusion on the ARTG.
14 May 2021
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
29 March 2021
It is alleged the company breached the Therapeutic Goods Act 1989 in relation to the importation of surgical face masks.
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.