The Unregulated Dental Laboratory Products Myth
30th Jul 18
The perception found in some sections of the dental community that dental laboratory products such as dental crowns and dental bridges are "unregulated" is entirely incorrect and addressed in a course offered later this year.
Key Issues For The Dental Industry —
The regulatory standards for dental laboratory products are robust and provide high levels of patient safety with the Australian Dental Industry Association (ADIA) working with stakeholders from the dental community and government to raise awareness and compliance with these regulatory standards.
A half-day course offered by ADIA introduces the role of the nation’s medical device regulator, the Therapeutic Goods Administration (TGA), in setting and enforcing the standards for dental laboratory products. The course also explains the regulatory standards that provide a high degree of patient safety as they set out the design, performance, and manufacturing quality obligations. It goes a long way to debunking the myth that dental laboratory products in Australia are unlimited.
Delivered by Ms Clare Martin, an expert consultant on medial device regulation who advises ADIA and many businesses across the sector, the course is being offered in Sydney on 30 August 2018 and in Melbourne on 11 October 2018. Registrations can be made via the website at:
ADIA plays a lead role in the development of dental laboratory product standards as a result of its in-depth engagement with the TGA. Businesses that manufacture and import dental laboratory products come together under the umbrella of the ADIA-LIG Laboratory Interest Group to help the sector understand its regulatory compliance obligations.
The work of the ADIA membership in coming together and helping the TGA enhance the regulatory framework for dental laboratory products is only one focus of the ADIA-LIG Laboratory Interest Group. The group also works to raise compliance levels and that is what this course is all about.
Member Engagement —
Members serving on the ADIA-LIG Laboratory Interest Group provide advice and guidance to the ADIA policy advocacy team on matters associated with the regulation of dental laboratory products (custom-made medical devices) and updates are available to members at the quarterly ADIA State Branch Briefing series.
Further Information —
To keep up to date with matters associated with dental product regulation 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 firstname.lastname@example.org or by telephone on 1300 943 094.
Currency Of Information & Disclaimer —
This update was issued on 30 July 2018 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 publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, images and where stated.
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