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Class IIa
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Based on the selections you have made; your device classification is Class IIa.
About Class IIa
Devices of this classification are of low-moderate risk.
They require conformity assessment certification for the manufacturer of the device before they can be included in the Australian Register of Therapeutic Goods (ARTG).
The certification can be provided by either the TGA or a European Notified body.
Note: some devices have more than one classification. The higher of the classifications is the correct one.
More information
- Medical device regulation basics
- Australian Regulatory Guidelines for Medical Devices (ARGMD)
- Application for conformity assessment certificates
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