9 December 2021
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.
26 November 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.
16 November 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.
5 November 2021
Action in relation to non-compliant face masks will be published on the TGA web site
8 September 2021
This page compiles all of our resources related to face masks and COVID-19.
18 August 2021
Information about a TGA post-market review of face masks, including guidance for suppliers and users of face masks.
10 August 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.
31 January 2021
What you need to know before you seek to import personal protective equipment (PPE) into Australia during the COVID-19 pandemic.
29 January 2021
Two emergency exemptions that were made to facilitate the supply of ventilators and personal protective equipment in Australia during the COVID-19 emergency will cease on 31 January 2021.
28 January 2021
Information relating to face masks and gowns to assist healthcare organisations as they update their operating procedures during the outbreak