TGA Compliance Courses -
Introducing the Basics
Supplying dental products in the Australian market isn’t straight-forward and the Therapeutic Goods Administration (TGA) places several requirements on manufacturers and suppliers. This training module will strengthen your career in the dental industry by introducing the work of the TGA and key regulatory concepts – it provides the knowledge to explain to your team members and customers the broad legal framework in which dental products are supplied.
This training module is presented in lay 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 outcomes 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.
This course is designed for dental industry employees who require a base-level overview of the regulatory standards for the approval of dental products/medical devices such as managers (without direct responsibility for statutory compliance) and front-line sales staff.
Unit 1 — Medical device regulatory framework overview
A broad overview of the role of the Therapeutic Goods Administration (TGA) and its legislation.
Unit 2 — Medical devices and dental products
A review of the definition of a medical device and what dental products constitute a medical device and why.
Unit 3 — Medical device classification
The rationale for classifying medical devices according to risk, an explanation of the classification rules and practical examples of why certain medical devices are classified as they are.
Unit 4 — Medical devices and safety
An overview of the ‘essential principles’ and how they relate to the manufacture and use of dental products.
Unit 5 — Medical device manufacturing, importing and supply
The roles and responsibilities of manufacturers and importers of medical devices as ‘sponsors’ and the different pathways that medical devices can be lawfully supplied in Australia.
Unit 6 — Medical device registration
An introduction to the Australian Register of Therapeutic Goods (ARTG), what information it contains, and why the same product may appear several times.
Unit 7 — Medical device sponsor obligation
A review of the obligations that medical device sponsors have including record keeping, incident reporting, and recall management.
Unit 8 — Medical device case study
A fictional case study of the steps taken by a supply company from the time of deciding to import a product through to when it can be lawfully supplied in Australia
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). This one-day course is scheduled to be held in:
Thursday, 1 November 2018
Thursday, 11 October 2018
This highly educative module seeks to break down the complexity of the TGA’s regulatory standards by presenting the information in a manner the lay-person can understand. 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 2: Class I medical device regulation, and Module 3: Dental laboratory product 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-DRC Dental Regulation 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 email@example.com or by telephone on 1300 943 094.