22 October 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.
30 September 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.
22 September 2021
The TGA has issued two infringement notices totalling $26,640 to Tianda Pharmaceuticals Australia Pty Ltd for alleged unlawful advertising of a listed medicine in relation to COVID-19.
8 September 2021
This page compiles all of our resources related to face masks and COVID-19.
18 August 2021
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.
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.
23 July 2021
The TGA has issued an infringement notice for $2,664 to an individual from Canberra, for a breach of the Therapeutic Goods Act 1989 in relation to the alleged unlawful advertising of a homoeopathic medicine with COVID-19 claims.
2 July 2021
The TGA has issued seven infringement notices totalling $93,240 to Melbourne-based global biopharmaceutical company Starpharma Holdings Limited (Starpharma), for alleged illegal advertising of a nasal spray that is not approved for use in Australia.
10 June 2021
The TGA has issued two infringement notices totalling $26,640 to Sydney company Aidacare Pty Ltd (Aidacare).