Buying Quality Dental Equipment, Products & Services
In the same way that the professional responsibilities of dentists and allied oral healthcare professionals are heavily regulated in Australia, so too is the supply of dental equipment, products and services. The Therapeutic Goods Administration (TGA) is the Australian Government agency that regulates this aspect of Australia’s oral healthcare sector. For a quick guide about buying dental products and services, please download:
The arrangements that regulate the supply of dental product in Australia are complex and members of the Australian Dental Industry Association (ADIA) have the expertise and commitment to working with dentists and allied oral healthcare professionals to ensure that only quality product that complies with the relevant standard is available for you to use.
What equipment and products are regulated?
Many products used in modern dentistry are classified as therapeutic devices under the regulations administered by the TGA. The legislation refers to those products that are used for humans; have therapeutic benefits; generally have a physical or mechanical effect on the body or are used to measure or monitor functions of the body.
The type of product used includes not only many common products used in dentistry such as braces, fillings and dental tools such as syringes, but also a wide range of mainstream healthcare equipment and products including artificial hips, blood pressure monitors, breast implants, catheters, lubricating eye drops and tongue depressors.
What are the standards?
In most cases the TGA references Australian Standards (AS), joint Australian / New Zealand Standards (AS/NZS) or documents published by the International Standards Organisation (ISO), with the TGA sometimes making minor changes of a technical nature to reflect local practice.
The standards often specify not only the design criteria for the piece of equipment or consumable, they also often set out ongoing processes to verify quality during manufacture and where required prescribe installation, maintenance and calibration processes.
These standards are produced with considerable technical input from dentists and industry, with ADIA taking a lead role in this work.
What is the role of industry?
Dentists and allied oral healthcare professionals need to have confidence that the equipment and consumables they use on patients are safe. To ensure this, ADIA members proactively ensure that, where required, their products comply with the relevant standards referenced by the TGA.
Most dental equipment and consumables in Australia are imported, predominately from North America or Europe, however the legislative arrangements are fundamentally the same whether the products are imported or manufactured locally.
ADIA members comply with regulations that require them to make an application to have product items listed on the Australian Register of Therapeutic Goods (ARTG) when they are offered for sale in Australia. Importantly, even if one company is importing a particular brand of device, TGA requirements are such that all other importers of the same particular brand of device are required to apply to have the device listed on the ARTG. This is part of the reason it is not practical, nor indeed legal, for dentists to buy product and consumables from overseas and use it in their surgery without going through the complex and costly process of seeking TGA approval to list the product on the ARTG.
Australia’s dental industry plays an important role supporting dentists and allied oral healthcare professionals provide quality product and consumables to Australians. This relationship between industry and the professionals that deliver dental services is important in building public confidence in the safety, performance, benefits and risks associated with the use of medical devices used in dentistry in the Australian market. ADIA’s role in this area is to keep industry (i.e. your suppliers) up to date with changes to regulations so as to ensure that dental equipment, consumables and services complies with TGA regulations.
If you are a dentist or allied oral healthcare professional purchasing dental equipment, consumables and services, make sure that your supplier is a member of ADIA, and if not ask why not ― it’s your professional reputation that is at stake.
For more information about ADIA’s work supporting the supply of quality dental products and services, contact the Association by email at dental.regulation@adia.org.au or by telephone on 1300 943 094 (internationally on + 61 2 9319 5631).