Reporting obligations of importers of dental laboratory products

Importers of dental laboratory products such as dental crows, bridges and veneers are being reminded of their legal obligation to notify the Therapeutic Goods Administration (TGA) of their activities. It’s part of a campaign by the Australian Dental Industry Association (ADIA), to raise awareness of a regulatory change introduced last year.

The TGA requires that—within two months of manufacturing or supplying a custom-made medical device (the legal definition of dental laboratory products)—the Australian manufacturer, or the Australian importer of a custom-made medical device that was manufactured overseas, must notify the TGA of their activity.

“Market analysis suggests that there is not widespread knowledge of the reporting obligation amongst those importing dental laboratory products,” ADIA CEO Troy Williams said.

“ADIA is working proactively to raise awareness of, and compliance with, this legal obligation.”

Compliance with the regulatory standards associated with importing dental laboratory products requires an importer to have access to a range of tests on the materials to ensure that they are safe, Williams added, “something important since dental laboratory products may spend many years inside a patient’s mouth.

“The tests can be complex and will look at everything from a toxicology risk assessment and the ability of the dental work to survive in the mouth which is a pretty hostile environment for materials. If an importer does not have access to these tests and the ability to provide them to the TGA when requested to do so, they are in clear breach of their legal obligations,” Williams said.

There is currently no charge for importers of dental laboratory product to report their activities to the TGA, as is required by law, via the online form.