The TGA has voiced its concerns that a culture of ignorance may exist amongst dentists and practice staff at present as to the magnitude of the changes brought into place under the Therapeutic Goods Act on 4 October, 2004.
The changes essentially mean that anything a dentist uses that comes into contact with a patient as a medical device must be listed on the Australian Register of Therapeutic Goods (ARTG) by an Australian 'sponsor'. The sponsor is responsible for ensuring that the medical device meets all the regulatory requirements, including applying to the TGA to have the product entered on the ARTG. Products that were previously exempt such as mouth mirrors and impression materials must now be listed and dentists are legally responsible for ensuring
everything that is placed in the patient's mouth is listed.
You can no longer directly import products into Australia to use in your practice on patients as these items do not have an Australian sponsor. This includes mail order or purchasing items at overseas dental shows.
There are also no exemptions for
personal use of products on your
The TGA and Customs will be actively policing illegal imports in the first instance but the real danger for dentists is that any lawsuit from an affected patient treated with a non-registered product may see your insurance supplier opting out of your defence.
Dental labs must also use products that are listed on the ARTG, but if they don't, it is the dentist's problem! Individual appliances and prosthesis are not subject to registration but all the components used in their manufacturer are. This will have a particular impact on dentists who are sourcing their lab work from overseas as it will be difficult to police.
The Australian dental industry has spent thousands of dollars on ensuring all the products they sell are listed with the TGA and compliant with the legislative changes. From a dental practice's perspective, it makes sense to reward their diligence with your patronage - the alternative could potentially be very costly.