The Obligations Of Dental Laboratory Product Importers
2nd Jul 18
Importers of dental laboratory products are being encouraged to review Australia’s regulatory standards to ensure their suppliers are aware of the design and construction principles that protect patient safety.
Key Issues For The Dental Industry —
Thanks to the rapid take-up of CAD-CAM technology, Australian dental laboratories are producing custom-made medical devices such as dental crowns and dental bridges at a fast rate. What’s not often understood is that those dental professionals who decided not to source locally but import products directly themselves have regulatory compliance obligations very much similar to local manufacturers.
Importers of dental laboratory products still have to meet what the nation’s medical device regulator, the Therapeutic Goods Administration (TGA), calls “essential principles”. These set out the design and construction standards to safeguard patient safety.
It’s important that importers of dental laboratory products work with overseas manufacturers to understand what the regulatory standards are. With respect to custom-made dental appliances, products manufactured by dental laboratories both in Australia and overseas are required to meet six general “Essential Principles” that apply to all medical devices which are as follows:
TGA Medical Device Essential Principles —
■. Use of a medical device not to compromise health and safety;
■. Design and construction of medical devices to conform with safety principles;
■. Medical devices to be suitable for intended purpose;
■. Long-term safety;
■. Medical devices not to be adversely affected by transport or storage; and
■. Benefits of medical devices to outweigh any undesirable effects.
There are a further nine "Essential Principles" about design and construction that apply to medical devices on a case-by-case basis. These provide minimum chemical, physical, and biological properties in addition to a range of matters not related to custom-made medical devices such as requirements for medical devices connected to or equipped with an energy source.
Importers of dental laboratory products, including dentists, need to have access to the technical dossier that explains how these standards have been met. This technical dossier is a complex document which is likely to contain everything from the chemical composition of the materials used to make dental crowns and bridges through to toxicology tests. The importers also need to be able to provide this information to the TGA upon requests.
ADIA offers a training course that helps both local manufacturers and also importers of dental laboratory products understand their regulatory obligations. Information on the course can be found via the link below:
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.
Importers of dental laboratory products are encouraged to join the ADIA-LIG Laboratory Interest Group to build their awareness of the regulatory compliance obligations that they have.
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 email@example.com 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.
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.
11th Apr 18
As the TGA acts to introduce an application fee for placing Class 1 medical devices on the ARTG, ADIA has meet with senior ministerial advisors in order to seek an outcome to alleviate the impact on the dental industry.