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Class Im
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Based on the selections you have made; the classification of your device is Class Im.
About Class Im
Class Im devices are lower risk.
They require conformity assessment certification for their manufacturer before they can be included in the Australian Register of Therapeutic Goods.
The certification can be provided by the TGA or a European Notified Body.
More information
- Medical device regulation basics
- Australian Regulatory Guidelines for Medical Devices (ARGMD)
- Application for conformity assessment certificates
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