The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued two infringement notices totalling $5,328 to a dentist from Western Australia, for the alleged unlawful importation of medical devices.
The dentist allegedly imported syringes containing hyaluronic acid that were not included in the Australian Register of Therapeutic Goods (ARTG).
Under the Therapeutic Goods Act 1989 (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).
Pre-filled syringes containing hyaluronic acid are medical devices used to change how parts of the skin look, and are often used to reduce lines and wrinkles on the face.
Cosmetic injections used in medical procedures can cause serious side effects. The TGA has published information to help you make an informed decision about cosmetic injections.
The TGA website also has a suite of cosmetic injection resources translated into various languages.
The TGA is concerned that there has been an increase in importing therapeutic goods, such as medical devices, not included in the ARTG for in-clinic use, and will be taking a strong enforcement approach to deal with breaches of this nature.
The TGA takes action against illegal activities
The regulatory scheme is critical to the safety of Australian consumers and the TGA investigates suspected illegal activity in relation to therapeutic goods. The range of compliance and enforcement tools available include substantial fines and criminal or civil court action.
If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.
