28 April 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.
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.
25 February 2021
The TGA has issued four infringement notices to Sydney-based company for the alleged unlawful importation of infrared thermometers, rigid strapping tapes and iodine prep pads.
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
28 January 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.
28 January 2021
The TGA has issued eight infringement notices to Sydney-based company for allegedly failing to provide information and face mask samples to the TGA when required to do so, and for providing false and misleading information.
13 January 2021
The TGA is undertaking a post-market review of all Point of Care and Laboratory tests included in the ARTG, which are intended to identify patients with COVID-19, to ensure they can detect the emerging SARS-CoV-2 genetic variants and remain accurate.
23 December 2020
The TGA has issued an infringement notice to Melbourne-based company Enviro Tech Holdings Pty Ltd for the alleged unlawful importation of surgical face masks in relation to COVID-19.