www.fdanews.com/articles/200058-tga-raps-sydney-firm-for-unlawful-importation-of-covid-19-devices
TGA Raps Sydney Firm for Unlawful Importation of COVID-19 Devices
November 18, 2020
Australia’s Therapeutic Goods Administration (TGA), which has been closely monitoring imports of unregistered devices during the COVID-19 pandemic, cited a Sydney-based company for alleged unlawful importing of infrared thermometers.
The CPAP Clinic allegedly imported noncontact infrared thermometers that were not included in the Australian Register of Therapeutic Goods (ARTG) and were not exempt or excluded from the TGA’s regulations.
Unless a specific exemption, approval or authority applies, devices must be entered in the ARTG before they can be sold in Australia, the agency said.