The Therapeutic Goods Administration (TGA) has issued two infringement notices totalling $25,200 to Queensland company CK Surgitech Pty Ltd for alleged breaches of the Therapeutic Goods Act 1989 (the Act).
It is alleged the company made a false or misleading statement in an application to have their IVD Rapid Test kits for SARS-CoV2 (the COVID-19 virus) included in the Australian Register of Therapeutic Goods (ARTG).
The company also 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 ARTG and were not being imported in relation to an authorised pathology laboratory as required by the Exemption.
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.
