Legal Radar

A Canberra dental practice has been fined $266,400 by the Therapeutic Goods Administration (TGA) for allegedly using dental implants and bone grafts that were not legally approved for supply in Australia.

The products were not listed on the official Australian Register of Therapeutic Goods (ARTG), which is required to make sure dental supplies meet safety and quality standards.

Because the implants and grafts were already placed in patients, the practice was told to inform those patients and give details about the products used.

The TGA explained that it takes this type of case seriously, as using unapproved dental products can put patients at risk.

The TGA also states that bypassing Australia’s approval system undermines public safety.

The regulator can issue fines, or even take civil or criminal action, to deal with unlawful supply of dental products.

Key Takeaways:

1. Only Use Approved Products - Any implant, graft, or device must be listed on the ARTG before being supplied or used.
2. Patient Safety Comes First - Using unapproved products exposes patients to risks and can damage trust in your practice.
3. Notification Obligations - If a non-approved product is used, practices may be required to notify every affected patient.
4. Financial and Legal Penalties - The Canberra case resulted in $266,400 in fines—a reminder that breaches can be very costly.
5. Possible Disciplinary Action - Beyond TGA action, AHPRA can be notified about practitioner conduct, which may lead to professional discipline.