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Exemption for coronavirus (COVID-19) medical devices
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, to support the purchase of certain kinds of medical devices by the Australian Government Department of Health for the National Stockpile. The exemption continues to support the Australian Government's rapid response to the COVID-19 emergency by facilitating access to certain kinds of medical devices intended to assist in reducing the transmission of infection between individuals, particularly patients and health care professionals.
The exemption only applies in relation to goods that are not already included in the Australian Register of Therapeutic Goods in the name of the supplier. The exemption does not permit the general supply of these items by sponsors to health care facilities or consumers.
The TGA is supporting suppliers of products used in the treatment of patients with COVID-19 which are not covered by this exemption to include them the ARTG as a priority.
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.