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Class Is
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Based on your selections, the classification of your medical device is Class Is.
About Class Is
Class Is medical devices are considered to be of lower risk. They require conformity assessment certification for their manufacturer before they can be included in the Australian Register of Therapeutic Goods (ARTG).
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 (forms and guidance)
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