IVD Australia: The Use of GMDN Codes for IVDs in Australia
Course Description:
This course gives a detailed background of how Global Medical Device Nomenclature (GMDN) codes are used to group IVD devices for inclusion in the Australian Register of Therapeutic Goods (ARTG).
The course covers the following topics:
- An introduction to the GMDN for IVD devices
- The structure of code tables
- Grouping provisions for ARTG entries (with examples)
Learning Objectives:
Upon successfully completing this course, trainees will be able to:
- Understand the relationship between GMDN codes and the grouping of IVDs for ARTG entries
- Apply GMDN codes to the range of IVDs marketed in Australia
- Determine the number of ARTG entries required for various products
Who Should Enroll:
Regulatory affairs managers, quality assurance managers, and marketing managers driving the market access for IVD devices in Australia are all 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)