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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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14 January 2021
The TGA is undertaking a post-market review of face masks included in the ARTG. This page lists all face masks that have been cancelled from the ARTG during the review.
13 January 2021
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
13 January 2021
A list of disinfectant products included in the ARTG with specific claims against SARS-Cov-2 (COVID 19) or COVID-19 on the product label.
13 January 2021
The TGA is undertaking a post-market review of all Point of Care and Laboratory tests included in the ARTG, which are intended to identify patients with COVID-19, to ensure they can detect the emerging SARS-CoV-2 genetic variants and remain accurate.
4 January 2021
What you need to know before you seek to import personal protective equipment (PPE) into Australia during the COVID-19 pandemic.
24 December 2020
An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves.
24 December 2020
Information about a TGA post-market review of face masks, including guidance for suppliers and users of face masks.
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.
23 December 2020
Guidance to assist manufacturers in choosing appropriate standards and to set out the TGA's expectations for performance testing of respirators, surgical respirators and medical/surgical facemasks, before inclusion on the ARTG.
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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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