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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
What you need to know before you seek to import personal protective equipment (PPE) into Australia during the COVID-19 pandemic.
31 January 2021
Information for sponsors and manufacturers about pathways for exporting a ventilator from Australia.
31 January 2021
The TGA has established an expedited recall pathway for faulty or unauthorised COVID-19 devices
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 assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
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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