IVD Australia: The use of GMDN codes for IVDs in Australia
This course provides medical device professionals with detailed background on how the 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 an introduction to the GMDN for IVD devices, details the structure of the code tables and explains the grouping provisions for ARTG entry with examples.
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Upon completion of this course, trainees will be able to understand the relationship between GMDN codes and the grouping of IVDs for ARTG entry and successfully:
- Apply GMDN codes to the range of IVDs to be marketed in Australia
- Determine the number of ARTG entries required for the range of products.
Regulatory affairs managers, quality assurance managers and marketing managers driving the market access for IVD devices in Australia.