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Two Sydney companies fined a total of $93,240 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 seven infringement notices totalling $93,240 to two Sydney-based companies: The CPAP Clinic Pty Ltd and JCIN Pty Ltd. The CPAP Clinic was fined $13,320 for alleged unlawful importation of infrared thermometers and JCIN was fined $79,920 for alleged advertising breaches in relation to medical devices. The Director of The CPAP Clinic is also the Director of JCIN.

The CPAP Clinic 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.

JCIN allegedly advertised pulse oximeters, KN95 respirator masks and non-contact infrared thermometers, on The CPAP Clinic's website, and stated 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.

JCIN also allegedly advertised, on The CPAP Clinic's website, KN95 masks with an inaccurate ARTG number that does not exist.

Under the Act, therapeutic goods advertising to consumers must comply with the Therapeutic Goods Advertising Code (the Code), which prohibits inaccurate advertising that is not truthful and correct.

Breaches of the Act and the Code 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.

The TGA website includes tips for consumers about how to spot a dodgy health product ad.