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Ventilators permitted for supply under COVID-19 Emergency Exemption
On 8 April 2020 the Therapeutic Goods (Medical Devices—Ventilators) (COVID-19 Emergency) Exemption 2020 was made to support the Australian Government's rapid response to the COVID-19 emergency by facilitating access to medical devices to treat patients requiring invasive ventilation. The exemption instrument remains in force until 31 January 2021. Manufacturers may not supply new ventilators after this date, but healthcare facilities may continue to use ventilators they have acquired under the exemption.
The following list is comprised of ventilators that meet the minimum requirements, as set out in Ventilator for COVID-19 use in Australia and have received permission to be supplied under the exemption to enable the domestic manufacture and supply of ventilators.
Ventilators supplied under this exemption have not had their safety and performance fully tested or reviewed by the TGA. Any ventilator manufactured using the exemption should only be used when ventilators that have regulatory approval by the TGA (i.e. included in the ARTG) are not available.
Ventilators supplied under this exemption have not received 'regulatory approval' by the TGA and manufacturers must not make any representation to this extent. The TGA strongly recommends that any healthcare facilities needing to use these devices conduct their own performance and usability validation.