Australia TGA Publishes Guidance Document on Global Medical Device Nomenclature (GMDN) Terms

Therapeutic Goods Administration (TGA) Australia has published a guidance document on the Global Medical Device Nomenclature (GMDN) Terms, which discusses about the information to support sponsors and manufacturers, in October 2021. 

The information presented is applicable to medical devices and Class 4 in vitro diagnostic (IVD) devices, however there are some differences for Class 1, 2 and 3 IVDs. Sponsors and manufacturers of these devices should be aware of these differences. 

GMDN Terms are an international naming and grouping convention used for the identification of medical devices and are used to ensure consistency in the description of these medical devices. In Australia, GMDN Terms are important in determining a ‘kind’ of medical device. 

Devices are considered to be of the same kind if they have the following characteristics: the same Sponsor, the same Manufacturer, the same classification, the same GMDN Term, and the same unique product identifier (for Class III medical devices, Class AIMD medical devices and Class 4 IVD devices). 

More details can be found in “Global Medical Device Nomenclature (GMDN) Terms: Information to support sponsors and manufacturers”, Version 1.0, October 2021”:  

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