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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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28 April 2020
Advice for faecal microbiota transplant (FMT) providers on safety protections related to COVID-19.
24 April 2020
The TGA has issued an infringement notice for $2,520 to a woman in Western Australia for alleged breaches relating to COVID-19 test kits.
24 April 2020
The TGA has issued an infringement notice for $12,600 to Labtest Direct for the alleged advertising of COVID-19 Rapid Test kits.
24 April 2020
The TGA has issued infringement notices totalling $25,200 to Queensland company CK Surgitech for alleged breaches relating to COVID-19 test kits.
24 April 2020
Where suitable, TGA inspectors will undertake remote and/or hybrid Good Manufacturing Practice (GMP) domestic inspections during the COVID-19 pandemic.
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.
1 April 2020
COVID-19 tests must be done under the direction of a health professional. The advertising and sale of home tests is prohibited.
31 March 2020
Clarification about the clinical trial process as it relates to COVID-19
27 March 2020
The alleged contraventions relate to the advertising of hyperbaric oxygen therapy chambers, not included in 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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