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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.
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A list of self-tests that are approved in Australia
Find information about the supply of COVID-19 rapid antigen self-tests to assist sponsors, manufacturers and consumers. Also includes information about the detection of multiple respiratory targets such as influenza A, influenza B and COVID-19 in a single rapid antigen test format (Combination...
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.
Find out about the different ways we test for COVID-19 in Australia.
Find out information about the different types of tests and how the TGA assesses them and monitors their performance.
Information about the post-market review of all approved COVID-19 tests and a post-market evaluation of all approved serology-based COVID point-of-care tests.
Contact TGA Info
Tel: 1800 020 653
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.