TGA Rescinds COVID-19 Emergency Use Authorizations for Ventilators, PPE
Australia’s Therapeutic Goods Administration (TGA) has withdrawn emergency COVID-19 exemptions for ventilators and personal protective equipment (PPE) because there is no longer a supply shortage in the country.
When the emergency exemptions were issued last spring, they allowed ventilators and PPE to be manufactured to certain minimum technical requirements without meeting the more stringent requirements under Australian regulations. But this meant that products that could be supplied under the exemption were not TGA-approved.
Starting Feb. 1, all ventilators and PPE must meet TGA regulatory requirements and be listed on the Australian Register of Therapeutic Goods, the agency said.