The Therapeutic Goods Administration (TGA) has issued an infringement notice for $2,520 to a woman in Western Australia for alleged breaches of the Therapeutic Goods Act 1989 (the Act).
The woman allegedly breached a condition of the Therapeutic Goods (Medical Devices-Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020 (the Exemption) by importing COVID-19 test kits that were not included in the Australian Register of Therapeutic Goods (ARTG), and were not being imported in relation to an authorised pathology laboratory as required by the Exemption. These products are classified as Class 4 in vitro diagnostic (IVD) medical devices. Such products must not be imported into Australia unless they are included in the ARTG, or meet the conditions of the Exemption. The Australian Border Force detected the importation by the woman at the border.
