The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued an infringement notice for $12,600 to Western Australian-based company Medical Sales & Service Pty Ltd for the alleged unlawful importation of anaesthetic face masks.
Medical Sales & Service allegedly imported anaesthetic face masks that were not, at the time of the importation, 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). Under the Act, therapeutic goods must be entered in the ARTG before they can be lawfully imported into Australia, unless a specific exemption, approval or authority applies.
At the time of the alleged importation, the only exemption in place relevant to face masks was the Therapeutic Goods (Medical Devices-Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020. However, this exemption only applies to the kinds of medical devices that are designed to be worn by individuals to prevent the transmission of organisms. Examples of such devices include disposable face masks, disposable gloves, disposable gowns, and protective eye wear in the form of goggles, glasses or visors. Therefore, this exemption does not apply to respiratory anaesthetic face masks, which need to be included in the ARTG before they can be lawfully imported.
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.
