The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued two infringement notices, each for $12,600, to Melbourne-based companies Australian Beauty Group Pty Ltd and VeraTemp Pty Ltd for the alleged unlawful importation and advertising of medical devices in relation to COVID-19.
Australian Beauty Group 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 (the Act). Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully imported or advertised in Australia.
It is also alleged that advertising on the VeraTemp Pty Ltd website for non-contact infrared thermometers falsely suggested that the thermometers had been approved by the TGA, when no such approval has been given.
Advertisers must not make any statement that implies goods have been recommended or approved by a government (including the TGA or international regulators), except in very limited circumstances.
The TGA has informed Australian Beauty Group that the relevant advertisement must be immediately removed from the VeraTemp website. The Director of VeraTemp is also the Director of Australian Beauty Group.
These breaches of the Act are of significant concern to the TGA given the current pandemic. The TGA has published a .
The TGA’s highest priority is to protect the health and safety of the Australian public through our strict regulation of therapeutic goods – we will continue to pursue companies whose actions potentially risk people’s health.
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 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 online to the TGA.
Any person, including businesses, advertising therapeutic goods to consumers must comply with the . The TGA encourages people to report suspected non-compliant advertising via its .
The TGA website includes tips for consumers about ad.
