8 April 2020
Note: This advice is sourced from the Therapeutic Goods Administration (TGA). View all current TGA advice on COVID-19 here.
Recent modelling of the COVID-19 outbreak indicates that up to 8,000 ventilators may be required to treat patients in Australia. 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 new emergency exemption will be in effect until 31 January 2021 and will relate to ventilators that are not already included on the Australian Register of Therapeutic Goods (ARTG) in the name of the manufacturer and those which can demonstrate compliance with minimum technical requirements. The exemption does not permit the general supply of these ventilators to health care facilities or consumers outside the context of the COVID-19 emergency.
Ventilators supplied under this exemption must:
- be manufactured domestically in Australia;
- be supplied to Australian healthcare facilities only; and
- meet the specifications and testing requirements published in Ventilator for COVID-19 use in Australia.
Manufacturers will be required to demonstrate compliance with the specifications to the TGA.
The requirements for these devices as set out in Ventilator for COVID-19 use in Australia have been compiled by Australia’s Chief Scientist, Alan Finkel, with support from an expert panel of ICU clinicians from across Australia, the TGA and the Commonwealth Ventilator Taskforce.
Note
The exemption only applies to ventilators manufactured in Australia which are supplied for hospital use.
Ventilators supplied under the Exemption are only intended for use when purpose-made ICU ventilators which have been subjected to conformity assessment procedures and included on the ARTG, are not available.
The TGA will publish additional information that sets out the process and templates for how manufactures should submit their declaration and evidence of compliance to meet the above specification and the conditions in the exemption.
For further information on the novel coronavirus (COVID-19), please see the Department of Health and TGA websites.
View all current TGA advice on COVID-19 here.
