19 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).
18 January 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 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.
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.
23 December 2020
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.
10 December 2020
If you are considering supplying face masks (including respirators) that meet the definition of a medical device in Australia, you will need to apply for the inclusion of these products in the ARTG.
6 November 2020
Action in relation to non-compliant face masks will be published on the TGA web site
17 September 2020
Information relating to face masks and gowns to assist healthcare organisations as they update their operating procedures during the outbreak