The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued an infringement notice for $13,320 to Sydney-based company Livingstone International Pty Ltd for the alleged unlawful importation of infrared thermometers.
Livingstone International allegedly imported non-contact infrared thermometers that at the time of importation were not included in the Australian Register of Therapeutic Goods (ARTG) and were neither exempt nor excluded from the operation of the Therapeutic Goods Act 1989 (the Act). Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully imported in Australia.
Demand for thermometers has increased due to the COVID-19 pandemic. The TGA has published regulatory guidance to support sponsors with submitting their applications for thermometers to be included in the ARTG.
Breaches of the Act are of significant concern to the TGA given the current pandemic. The TGA’s highest priority is to protect the health and safety of the Australian public through regulation of therapeutic goods.
The TGA takes action against breaches of the Act
The regulatory scheme is critical to the safety of Australian consumers and the TGA investigates suspected illegal activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.
If you suspect non-compliance, you can report illegal or questionable practices online to the TGA.
