TGA Compliance Courses
Reporting Requirements — Dental laboratory products
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 only dental laboratory product knowledge at a level possessed by a dental product sales person, dental technician, dental prosthetist or dentist. It 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.
Unit 1 — Custom-made medical device regulatory framework overview
A broad overview of the role of the Therapeutic Goods Administration (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-DRC Dental Regulation 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:
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, electronic copy of the relevant legislation and a certificate of completion upon demonstrating an understanding of the learning outcomes.
If this course is of interest you may also want to register for Module 1: TGA Basics and Module 2: Class I medical device regulation which will also be offered by ADIA throughout the course of the year.
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 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 firstname.lastname@example.org or by telephone on 1300 943 094.
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