ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians...................... — ADIA Strategic Plan

TGA Compliance Courses
Dental Laboratory Product Regulation

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The legal framework for the supply of dental laboratory products is complex and this highly informative module will review the regulatory standards administered by the Therapeutic Goods Administration (TGA). This module provides stakeholders from across the dental community with a working knowledge of the legalities associated with the manufacture and importation of dental laboratory products (e.g. crowns, bridges, etc.).

This course is to be presented in layman’s terms and assumes that those attending have a strong knowledge of dental laboratory products but no idea how the TGA regulates them.

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.

Unit 1 —

Custom-made medical device regulatory framework overview
A broad overview of the role of the TGA and its legislation and why dental laboratory products constitute a custom-made medical device.

Unit 2 —

Custom-made medical devices and safety
An overview of the ‘essential principles’ and how they relate to custom-made medical devices.

Unit 3 —

Medical device sponsor obligations
A review of the obligations that medical device sponsors have including record keeping, incident reporting and recall management.

Unit 4 —

Custom-made medical devices and local manufacturing
The responsibilities of dental laboratories producing products within Australia and pathways to comply with the regulatory standards. It will include a fictional case-study from an Australian dental laboratory’s perspective.

Unit 5 —

Custom-made medical devices and importing
The responsibilities of those importing dental laboratory products from overseas and pathways to comply with the regulatory standards. It will include a fictional case-study from an importer’s perspective.

The course presenter is Ms Clare Martin, who is a prominent member of the ADIA-PRPC Product Regulation Policy Committee, an ADIA representative on the TGA Regulatory and technical forum for the devices sector, and a member of the Association of Therapeutic Goods Consultants (ATGC). The details on this one-day course are listed below:

Enrol today to secure your training place —

Sydney


Melbourne


Brisbane

Thursday, 7 February 2019
Thursday, 15 August 2019

Wednesday, 19 June 2019
Wednesday, 23 October 2019

Wednesday, 20 March 2019

This module will introduce many of the key regulatory concepts associated with custom-made medical devices used in dentistry and highlight the obligations that many professionals across the dental community overlook. All course participants receive a detailed set of learning materials and an electronic copy of the relevant legislation.

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-ISPC Industry Skills Projects Committee with technical advice from members serving on the ADIA-LIG Laboratory Interest Group.

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 training@adia.org.au 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.

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