IVD Australia: Obtaining a TGA Conformity Assessment Certificate for IVD devices
Course Description:
This course describes conformity assessment and examines the process for obtaining a Conformity Assessment Certificate from the Australian Therapeutic Goods Administration (TGA), including the timeframes for assessment. It also explains what happens once an application is deemed successful or not and the ongoing responsibilities of the manufacturer after a certificate has been obtained.
Learning Objectives:
Upon successfully completing this course, trainees will be able to:
- Determine the circumstances in which a TGA Conformity Assessment Certificate is required
- Understand the process, requirements, and responsibilities for making an application for a TGA Conformity Assessment Certificate
- Identify which documents the TGA needs to support applications for certification
Who Should Enroll:
Regulatory affairs professionals driving market access for IVDs in Australia are welcome to enroll in this course.
Prerequisite Knowledge/Requirements:
The following course is required:
- IVD Australia: Basics for Including an IVD on the ARTG (ID N150)