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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 January 2021
Information relating to face masks and gowns to assist healthcare organisations as they update their operating procedures during the outbreak
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
If you are considering supplying face masks (including respirators) that meet the definition of a medical device in Australia, you will need to apply for the inclusion of these products in the ARTG.
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).
28 January 2021
The TGA has issued eight infringement notices to Sydney-based company for allegedly failing to provide information and face mask samples to the TGA when required to do so, and for providing false and misleading information.
23 December 2020
The TGA has issued an infringement notice to Melbourne-based company Enviro Tech Holdings Pty Ltd for the alleged unlawful importation of surgical face masks in relation to COVID-19.
23 December 2020
The TGA has issued an infringement notice to Brisbane-based company PPE Direct Pty Ltd, trading as Infinity Biotech for the alleged unlawful advertising of a COVID-19 Rapid Test kit under the Therapeutic Goods Act 1989.
18 December 2020
The TGA has issued three infringement notices totalling $7,992 to a Sydney man for the alleged unlawful advertising of a disinfectant and a hand sanitiser in relation to COVID-19.
17 December 2020
The TGA has issued four infringement notices totalling $10,656 to a West Australian man, for alleged unlawful advertising of cannabidiol (CBD).

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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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