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The pace of developments within dentistry mean it is more important than ever to remain compliant with current rules and regulations. By Tracey Porter
In 2021 a Canberra dentist was fined $266,400 after being accused of importing and supplying illegal dental implants and bone grafts.
Twelve months later it was the turn of a Western Australian dentist who was fined more than $5000 and had their goods seized at the border after being found to have imported more than 20 vials of a prescription-only medicine not approved for use in Australia.
More recently, the increasing cost of medical supplies and a surge in online auction sites have compelled some dentists and practice owners to purchase counterfeit or unapproved equipment for use in their practices.
Now, the mainstream adoption of AI in dentistry and an increase in bespoke custom dental devices have put increased pressure on those charged with policing the sector, and muddied the waters for dentists attempting to ensure the tools they source to do their jobs do not violate the law.
Enter the TGA
Australia has a robust framework for regulating medical devices which is intended to ensure they are safe and fit for their intended purpose.
The Therapeutic Goods Administration (TGA) regulates dental medical devices, ensuring they meet safety, quality and performance requirements.
A TGA spokesperson says the regulations also ensure approved devices will perform as expected throughout their life.
“[Moreover] using [unapproved] devices can lead to significant risks including patient harm and financial loss for the dentist if something goes wrong, as their medical indemnity insurance may not cover them when using unapproved devices.”
The dental sector plays a critical role in public health and ensuring access to safe and effective devices is a shared responsibility between manufacturers, sponsors, health services, insurers, governments, and practitioners.
Generally, the TGA’s work involves ensuring devices meet pre-market requirements, are included in the Australian Register of Therapeutic Goods (ARTG) and are monitored for ongoing performance after they’re supplied.
With non-compliant items ranging from dental X-ray machines and handpiece drills to root canal files and dental turbines, the concern is medical devices purchased online or otherwise, that are not included in the ARTG, have not been subject to the same requirements for safety, quality, or performance.
Adapting the rules to changing times
The TGA continues to work hard to make changes to address the risks emerging from new technologies and practices.
In 2020, a new framework for the regulation of personalised medical devices was introduced. Based on feedback, refinements were then made to the framework, specifically for devices manufactured and supplied through practice.
Those changes included regulating the materials dental professionals use in practice to make devices for patients and providing an exemption from ARTG inclusion for those devices.
Take care when buying off the internet from overseas companies. Ensure their products are registered and compliant. To be honest, just deal with companies that are based in Australia and know our system.
Dr Scott Davis, former ADA President
In 2024, the rules around making and adapting personalised medical devices for patients were further strengthened.
“New manufacturing technologies are allowing more complex and personalised devices to be manufactured by health professionals, or with health professionals, as a part of their practice. Those new methods change the risk profiles of devices, and the regulatory framework should remain fit for purpose and balance the need for patient safety with access to more personalised devices by healthcare professionals.”
Where problems lie
The TGA concedes custom-made dental devices continue to present unique regulatory challenges. Because it’s difficult to have a pre-market assessment process for a bespoke device, they are typically exempt from ARTG inclusion but are subject to other regulatory requirements.
“Manufacturers must still be able to demonstrate that their device meets requirements, such as design and construction (known as the Essential Principles of Safety and Performance) and keeping appropriate records.”
The increasing use of AI in the sector—whether through diagnostic imaging tools or patient management systems—is also putting pressure on regulatory bodies to help ensure all stakeholders are compliant.
The TGA has previously developed guidance on software as a medical device (SaMD) to ensure developers of these kinds of AI-based tools know how to meet safety and performance standards for their products.
However, keeping pace with AI innovations requires ongoing adjustments to regulations and updated information for stakeholders, the TGA admits.
“Last year the Australian Government announced new measures to address the increasing use of AI. The TGA completed a review of its legislation as a part of that work, and the findings indicated the regulatory framework is largely adequate to meet the challenges associated with AI. [However], there are some opportunities for refinements so that we can continue to meet the challenges and to communicate regulatory expectations and how practitioners can use these kinds of products safely.”
Too much regulation?
Not everyone in the profession agrees with the assertion that further regulatory restrictions are required.
Prosthodontist and immediate past-president of the Australian Dental Association (ADA), Dr Scott Davis, believes current regulatory processes are robust enough to cope with any changes that may lie ahead.
He worries that excessive regulation could lead to innovation being stifled.
Instead, Dr Davis argues the onus should be on dentists to avoid direct importation of products that are not compliant and recommends practice owners regularly check the TGA website for updates, subscribe to regulatory newsletters, and engage with peak professional bodies like the ADA to ensure they remain compliant with regulations.
“Take care when buying off the internet from overseas companies. Ensure their products are registered and compliant. To be honest, just deal with companies that are based in Australia and know our system. If in doubt, ask for written confirmation that the goods are compliant with all Australian regulations.
“Don’t cut corners to save a few dollars, because in the long run it will cost you a lot more than you saved.”
