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).