The Therapeutic Goods Administration (TGA) has issued an infringement notice to a woman in Western Australia for alleged breaches of the Therapeutic Goods Act 1989 (the Act). The value of the infringement notice is $2,520.
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 3 in-vitro diagnostic (IVD) medical devices. COVID-19 test kits must not be imported into Australia, or manufactured or supplied in Australia, unless they are included in the ARTG or are subject to a relevant exemption, approval or authority.
