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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.

28 April 2021
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
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.
9 March 2021
Due to the unprecedented pressures COVID-19 has placed on the pharmaceutical industry, sponsors of listed medicines and registered over-the-counter (OTC) and complementary medicines (RCM) are eligible to request consent not to comply with TGO 92 labelling requirements for a limited time.
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

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
The TGA has established an expedited recall pathway for faulty or unauthorised COVID-19 devices
31 January 2021
To assist healthcare facilities, the TGA has provided guidance to assist with sourcing additional equipment to treat patients in the event of a shortage of ventilators and other respiratory support devices.
31 January 2021
Information for sponsors and manufacturers about pathways for exporting a ventilator from Australia.
29 January 2021
Two emergency exemptions that were made to facilitate the supply of ventilators and personal protective equipment in Australia during the COVID-19 emergency will cease on 31 January 2021.

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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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