Training — TGA Compliance Courses
The manufacture and supply of dental products is highly regulated by the Therapeutic Goods Administration (TGA). To provide guidance to business across the dental industry on their regulatory obligations, the Australian Dental Industry Association (ADIA) has developed three training courses.
These modules introduce the Therapeutic Goods Act (Cth) 1989 and its regulations with a focus on dental product suppliers. Each of the three modules looks at what requirements need to be met when introducing a new product to market and the ongoing obligations that suppliers have.
Module – TGA Introducing the Basics
This training module is presented in layman’s terms and assumes only dental product knowledge at a level presented by a salesperson or dental professional. It assumes no knowledge of the TGA and its legislation. The learning outcome will be: A basic understanding of what dental products constitute a medical device; how such products can be lawfully supplied in Australia; the work of the TGA; and how it impacts upon manufacturers and importers of dental products. [Read More]
Module – Reporting Requirements
This module introduces the work of the Therapeutic Goods Administration (TGA), its legislation and the obligations of local manufacturers and importers. The learning outcomes are: An understanding of the TGA's role; the regulatory guidance on product safety; what suppliers must tell the TGA; product documentation requirements; and obligations of suppliers to report problems. [Read More]
The content has been developed by ADIA in concert with the TGA and is tailored to the needs of businesses supplying products to dentists and allied oral healthcare professionals. The course presenter is Ms Clare Martin, who is a prominent member of the ADIA-DRC Dental Regulation Committee, an ADIA representative on TGA technical committees and a member of the Association of Therapeutic Goods Consultants (ATGC). Further information on each of the modules is also available from the course brochures:
Those attending these courses receive unique insights on the regulatory standards for medical devices as the courses are developed and offered by the dental industry's representatives on the TGA committees tasked with providing industry input into proposals for regulatory reform. These courses are an unparalleled opportunity to learn from those leading regulatory reform.
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 the development of these courses with a regulatory focus, the team the ADIA national office receive advice and guidance from members serving on the ADIA-ISC Industry Skills Committee.
Further Information —
If you have an interest in ADIA's work to help businesses across the dental industry upskill their workforce, to keep up to date 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.
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