A Canberra dental practice has been fined more than $260,000 for allegedly supplying medical devices not approved for use in Australia.
The Therapeutic Goods Administration has issued 20 infringement notices to the ACT practice totalling $266,400 for the alleged rule breach.
The TGA allege the business imported and supplied patients with dental implants and bone grafts not allowed to be used in Australia.
Under the Therapeutic Goods Act 1989, products must be entered into the Australian Register of Therapeutic Goods (ARTG) for they can be given to patients. It is alleged the products supplied by the practice weren't registered.
"Implanted therapeutic goods cannot be recalled, therefore the TGA has asked the dentist to notify all affected patients," TGA said in a statement.
"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 said it didn't have information on the manufacturer of the illegal items but the products are registered with the United States' Food and Drug Administration.
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"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," TGA said.
"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."
