TGA Compliance Courses

The manufacture and supply of dental products is highly regulated by the Therapeutic Goods Administration (TGA). To provide guidance to businesses across the dental industry on their regulatory obligations, the Australian Dental Industry Association (ADIA) has developed two training courses.

These modules introduce the Therapeutic Goods Act 1989 (Cth) and its regulations with a focus on dental product suppliers. Each of the modules look at what requirements need to be met when introducing a new product to market and the ongoing obligations that suppliers have.

Education Delivered Online

More details will be provided as they become available.

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.

TGA Introducing the Basics Course Content - 

• Medical device regulatory framework
• Medical devices and dental products
• Medical device classification
• Medical devices and safety
• Medical device manufacturing, importing and supply
• Medical device registration
• Medical device sponsor obligation
• Medical device case study

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 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.

Dental Laboratory Product Regulation Course Content - 

• Custom-made medical device regulatory framework overview
• Custom-made medical devices and safety
• Medical device sponsor obligations
• Custom-made medical devices and local manufacturing
• Custom-made medical devices and importing

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).