Including an IVD on the Australian Register of Therapeutic Goods
Estimated Learning Duration of the Program:
205
Program Description
Program Description:
This suite of courses covers the process for obtaining marketing approval from the Therapeutic Goods Administration (TGA) for an IVD in Australia. It describes the basics of the regulatory system, the basis of grouping IVDs for inclusion on the Australian Register of Therapeutic Goods (ARTG) and the process of making application for ARTG inclusion. It also explains when overseas approvals can be used to support an application for ARTG inclusion and when a TGA-issued Conformity Assessment Certificate is needed and how to obtain one if necessary. Finally, it will explain the TGA fees and charges involved in making applications for ARTG entry or conformity assessment certification.
Learning Objectives:
Upon completion of this course, trainees will
- understand the process, requirements and responsibilities for making an application to include an IVD on the ARTG;
- know what overseas certification can be used to support an application, and when a TGA conformity assessment certificate is required;
- be familiar with the process for obtaining a TGA Conformity Assessment Certificate; and
- be able to determine the most cost-effective path for their applications in terms of the applicable TGA fees and charges.
Basics in Regulatory Affairs Certificate
| Course Title Click on a title to view course description | ID | Duration |
|---|---|---|
| IVD Australia: Basics for including an IVD on the ARTG | 150 | 44 |
| IVD Australia: The use of GMDN codes for IVDs in Australia | 151 | 45 |
| IVD Australia: Making application for inclusion on the ARTG | 152 | 33 |
| IVD Australia: Obtaining a TGA Conformity Assessment Certificate for IVD devices | 153 | 40 |
| IVD Australia: Fees for including an IVD device on the ARTG | 154 | 43 |
Program Pricing
Prices have not been set for this program.