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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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7 April 2021
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.
Regulation of thermometers and other temperature measuring medical devices and products for COVID-19
12 March 2021
In response to the COVID-19 pandemic, the TGA has received a significant number of thermometer applications. This guidance assists thermometer sponsors and manufacturers to meet their regulatory obligations.
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.
9 February 2021
The plan outlines five key strategies to strengthen Australia's vaccine vigilance system.
9 February 2021
A comprehensive system is in place to capture reports of adverse events following COVID-19 vaccination.
9 February 2021
Access the COVID-19 vaccine weekly safety report, and learn how the TGA continues to monitor the safety of vaccines so that we can detect and respond to any safety concerns
8 February 2021
Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate by the European Medicines Agency (EMA)
2 February 2021
The TGA has concluded that there is no specific risk of vaccination with the Pfizer-BioNTech COVID-19 vaccine in elderly patients.
31 January 2021
A list of ventilators that meet minimum requirements and are permitted to be supplied under the COVID-19 Emergency Exemption.
31 January 2021
What you need to know before you seek to import personal protective equipment (PPE) into Australia during the COVID-19 pandemic.
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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.
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