Reporting Dental Laboratory Product Imports
19th Sep 17
Importers of dental laboratory products such as dental crowns, bridges and veneers are being reminded of their legal obligation to notify the nation’s regulator of medical devices, the Therapeutic Goods Administration (TGA), of their activities.
Key Issues For The Dental Industry —
The Australian Dental Industry Association (ADIA) is working to raise an awareness of a regulatory requirement introduced in 2016 that requires Australian manufacturers and importers of dental laboratory product to report their activities to the TGA.
The TGA requires that, within two months of manufacture or supply of a custom-made medical device, the Australian manufacturer of a custom-made medical device or an Australian supplier of a custom-made medical device (the legal definition of dental laboratory products) that was manufactured overseas notify the TGA of their activity. The reporting requirement is relatively new and came about as a result of sustained policy advocacy by ADIA which saw the TGA act to strengthen the regulatory arrangements associated with the supply of dental laboratory products, particularly those which are imported.
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 at:
A review of online dental community forums provides strong indications that some businesses and dental professionals are importing dental laboratory products unaware of their legal obligations. It's in this context that ADIA has stepped-up efforts to work with stakeholders across the dental community to raise awareness of, and compliance with, the mandated reporting requirement.
One of the obligations for that importers of dental laboratory products have is to have documentation associated with a range of tests on the materials to ensure that they are safe, something important since dental laboratory products may spend many years inside a patient’s mouth. These 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 test reports and the ability to provide them to the TGA, they are in clear breach of their legal obligations.
ADIA has been successful in securing a number of changes to the regulatory environment for dental laboratory products with the aim of ensuring that patients can have complete confidence in the safety of the treatment options being offered to them. In actively lobbying for reform to dental laboratory product regulation, the ADIA membership is seeking a regulatory framework for dental products that is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.
Member Engagement —
ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. With respect to to matters associated with the regulation of dental laboratory products and other medical devices, ADIA staff responsible for negotiating policy outcomes with government receive advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee and the ADIA-LIG Laboratory Interest Group. Member updates are provided at the quarterly series of ADIA State Branch Briefings.
Further Information —
If you have an interest in ADIA's efforts to reform the regulatory standards for dental products subscribe to the Twitter feed @AusDental or follow us on Facebook at www.facebook.com/dental.industry. Alternatively, you can contact the Association via email at email@example.com or by telephone on 1300 943 094.
Currency Of Information & Disclaimer —
This update was issued on 19 September 2017 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.
This information is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.
|A —.. A D I A . .S T R A T E G I C . .A L L I A N C E S
27th Jun 18
ADIA members continue to play a lead role shaping the regulatory framework for 3D printing in healthcare as it meets again with the Therapeutic Goods Administration (TGA) to progress regulatory reforms.
3rd Feb 18
A senate committee has recommended passage of legislation that will cut the the red tape associated with introducing new dental products to the Australian market. It's a legislative reform that ADIA has long argued for.