Information For Suppliers — Importing dental product
Importing dental products into Australia is not straight-forward as the Australian Government has put in place a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and performance of medical devices. This framework applies across the spectrum, from the simple hand tools used in dentistry to equipment such as autoclaves and dental implants.
Under Australian law most therapeutic devices need to be supplied in accordance with the framework established by the Therapeutic Goods Act (Cth) 1989. This legislation is administered by the Therapeutic Goods Administration (TGA) which regulates the quality, safety and performance of medical devices (e.g. dental equipment) that are manufactured, imported and / or supplied in Australia. The following documents provide an overview of the regulatory framework and standards that must be adhered to:
Documents for importers of dental product
ADIA - Guide to importing dental products into Australia (PDF)
TGA - Importing and supplying medial devices (PDF)
TGA - Australian regulatory guidelines for medical devices (PDF)
The Australian Dental Industry Association (ADIA) encourages an open market which supplies dentists and oral healthcare professionals with a range of products at a competitive price. Underpinning this is the need for confidence that the products supplied by the dental industry are safe and comply with the standards and regulations designed to achieve this outcome.
The legislation governing the importation of medical devices in Australia is subject to constant review and in order to ensure that your company is aware of and understands the changes, ADIA membership is a natural prerequisite for any importer.
Please note that ADIA will not provide advice to non-members about the regulatory framework. A general overview on matters affecting the dental industry is available by following ADIA on Twitter @AusDental and for information on membership please contact the ADIA national office via email at firstname.lastname@example.org or telephone 1300 943 094 (internationally on +61 2 9319 5631).