Haimex International Pty Ltd fined $53,280 for alleged unlawful importation of medical devices

Source: Australian Department of Health

The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued four infringement notices totalling $53,280 to Sydney-based company Haimex International Pty Ltd (Haimex International) for the alleged unlawful importation of infrared thermometers, rigid strapping tapes and iodine prep pads under the Therapeutic Goods Act 1989 (the Act).

Haimex International allegedly imported the products, which had not been included in the Australian Register of Therapeutic Goods (ARTG), and were neither exempt nor excluded from the operation of the Act. Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully imported into Australia. The TGA notified Australian Border Force that the goods should be seized.

Demand for thermometers in Australia has increased due to the COVID-19 pandemic. The TGA has published regulatory guidance to support business with submitting their applications for thermometers to be included in the ARTG.

Unapproved therapeutic goods imported unlawfully are of unknown reliability, and their importation in the context of the pandemic is of significant concern to the TGA.

The TGA’s highest priority is to protect the health and safety of the Australian public through the 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.