Medical Device Grouping allows for a simplification of the application process, which in turn, is more cost effective and time saving for the manufacturer. To be grouped together, the products will need to adhere to the specific rules to belong to certain categories. Medical Devices are included in the ARTG as a ‘kind of medical device’ and therefore can be “grouped” if they have the following:
the same Sponsor
the same Manufacturer
the same Classification
the same Global Medical Device Nomenclature System Code (GMDN code)
In order for Class III, Class AIMD medical devices, and Class 4 IVD medical devices (other than an immunohematology reagent that is a Class 4 IVD medical device) to be grouped they must have the same Unique Product Identifier (UPI).
Contact Asia Actual for more information about Australia grouping requirements.