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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.

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
Information for sponsors and manufacturers about pathways for exporting a ventilator from Australia.
31 January 2021
What you need to know before you seek to import personal protective equipment (PPE) into Australia during the COVID-19 pandemic.
28 January 2021
Information to help ensure individuals and organisations clearly understand and minimise the risks of reusing face masks and gowns.
28 January 2021
Guidance to help determine when a face mask is a medical device and therefore must be included in the Australian Register of Therapeutic Goods (ARTG).
26 August 2020
Important information about the use of COVID-19 point-of-care tests.
3 June 2020
New modelling demonstrates that supply of critical medicines for ventilating patients supports a return to elective surgery.
16 April 2020
During the COVID-19 pandemic, many businesses are encountering therapeutic goods regulations for the first time. This information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations.
7 April 2020
This new specification details the minimum technical requirements for manufactured invasive ventilators when approved devices are not available during the COVID-19 emergency.

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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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