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Cleanstar Pty Ltd fined $53,280 for alleged unlawful importation and advertising of medical devices

29 October 2020

The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued four infringement notices totalling $53,280 to Melbourne-based company Cleanstar Pty Ltd for the alleged unlawful importation of infrared thermometers and advertising breaches in relation to face shields and surgical face masks.

Cleanstar allegedly imported 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.

It is also alleged that Cleanstar advertised face shields and surgical face masks, on the company's website, and suggested the medical devices had been approved by the TGA.

Promoting products as "TGA listed", or including other government endorsements, whether they are included in the ARTG or not, is a breach of the Act. The TGA has published guidance on how advertisers can lawfully advise consumers that a product is 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.

Any person, including businesses, advertising therapeutic goods to consumers must comply with the requirements for advertising. The TGA encourages people to report suspected non-compliant advertising via its advertising complaints form.

Visit the TGA website for tips about how to spot a dodgy health product.