The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued twenty infringement notices totalling $266,400 to a Canberra-based dental practice. The alleged breaches of the Therapeutic Goods Act 1989 (the Act) include the importation and supply of dental implants (medical devices) and bone grafts (biologicals) that were not approved for use in Australia.
It is alleged that the company imported, supplied and implanted medical devices and biologicals in patients that were not entered into the Australian Register of Therapeutic Goods (ARTG).
Under the Act, therapeutic goods must be entered into the ARTG before they can be lawfully supplied in Australia (unless a specific exemption, approval or authority applies).
Implanted therapeutic goods cannot be recalled, therefore the TGA has asked the dentist to notify all affected patients. The advice to patients contains information about the implanted products and the ongoing management of their implants. Patients who have concerns should seek advice from a registered dental practitioner.
The TGA does not hold information regarding the manufacturer of the unregistered goods, however is aware that the products are registered with the Food and Drug Administration (FDA) in the United States of America.
In Australia, the inclusion of therapeutic goods in the ARTG, through the regulatory approval process, is an important safeguard to ensure the safety, quality and performance of products. Medical devices and biologicals go through strict approval assessments before they are entered in the ARTG and are available for supply in Australia.
The TGA is particularly concerned about the actions of health practitioners who undermine the regulatory scheme. To address these types of breaches, the TGA is taking a pro-active approach to safeguard the health and safety of the Australian public.
The TGA takes enforcement action
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.
If you have concerns about health practitioners, notify the Australian Health Practitioner Regulation Agency (AHPRA).
