Exemption for Coronavirus (COVID-19) Medical Devices (TGA)

24 March 2020

The Therapeutic Goods Act 1989 (the Act) provides that the Minister for Health (or his delegate) may exempt certain kinds of medical devices that are not included in the Australian Register of Therapeutic Goods from various provisions of the Act so that those devices can be made available urgently to deal with public health emergencies. On 22 March 2020, the Secretary, as delegate of the Minister, made the Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020, in order to facilitate necessary access to certain kinds of medical devices under contract with the Australian Government Department of Health, or another agency of the Commonwealth acting on behalf of Australian Government Department of Health, that are used for the prevention, monitoring, treatment or alleviation of novel coronavirus (COVID-19) infection. (In practice, disposable face masks, disposable gloves, disposable gowns, and protective eye wear in the form of goggles, glasses or visors, which are designed to be worn by individuals to prevent the transmission of organisms.)

The exemption may be viewed on the Federal Register of Legislation.

For further information on the novel coronavirus (COVID-19), please see the Department of Health website.




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