You are here
Coronavirus (COVID-19): Information on medicines and medical devices
The TGA is publishing the latest information about medicines and medical devices as it relates to COVID-19 on this page.
Please read the information below before contacting the TGA to see if your question is already answered.
Filters
Topics and product types
I want to
- Find out about medicine shortages and restrictions (2) Apply Find out about medicine shortages and restrictions filter
- Gain access to TGA Business Services to become a sponsor (2) Apply Gain access to TGA Business Services to become a sponsor filter
- Report a perceived breach or questionable practices (1) Apply Report a perceived breach or questionable practices filter
- Remove Supply a COVID-19 test kit filter Supply a COVID-19 test kit (8)
- Supply a face mask, gloves or gown (2) Apply Supply a face mask, gloves or gown filter
- Supply hand sanitiser, cleaner or disinfectant (5) Apply Supply hand sanitiser, cleaner or disinfectant filter
Filters applied:
13 January 2021
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
4 December 2020
Information for sponsors regarding the supply of COVID-19 tests, including advice for those sponsors new to therapeutic goods regulation in Australia
2 December 2020
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.
5 November 2020
This is current advice relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections
19 October 2020
The Doherty Institute has completed its validation of fifteen serology-based point of care tests as part of a TGA post market review. The TGA has requested the sponsors of these devices to provide further information on the clinical studies undertaken by the manufacturer to support the performance...
2 October 2020
All applications in relation to COVID-19 are being expedited as a matter of priority (separate to the Priority Review pathway)
26 August 2020
Important information about the use of COVID-19 point-of-care tests.
24 March 2020
Certain medical devices for the diagnosis and treatment of COVID-19 will be exempt from various provisions of the therapeutic goods act to facilitate necessary access
Further information
Contact TGA Info
Tel: 1800 020 653
Email: info@tga.gov.au
Note: we are currently experiencing a high volume of calls and emails. Please bear with us as we try to respond to queries as quickly as possible.
Department of Health
Coronavirus (COVID-19) health alert — for information and advice not specific to therapeutic goods.
Follow us
