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The classification system uses a set of classification rules based on the manufacturers intended use, the level of risk and the degree of invasiveness in the human body.
Products in Australia are classified into one of the following from lowest to highest risk:
The Australian classification system is similar to the European classification guidelines and the vast majority of devices previously registered in Europe will carry the same classification in Australia. There are proposed changes in the Australian Classification to further align with the European Classification.
AIMD devices and accessories | Class III |
Breast implants and surgical meshes | Class III |
Total and partial joint replacements | Class III |
Spinal disc replacement implants or implantable devices that come into contact with spinal column, with some exceptions (screws, wedges, plates and instruments) | Class III |
Contact Asia Actual for more information about the Australia classification system.
US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: Inquiry@asiaactual.com
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