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Group A - Class III solution (pre-determined)
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Based on the selection you have made, the classification of your device is Class III.
About Class III
Class III devices are considered to be high risk.
Useful links
- Medical device regulation basics
- Australian regulatory guidelines for medical devices (ARGMD)
- Application for conformity assessment certificates (forms and guidance)
Thank you for completing this tool. Please contact the TGA if you require further information or assistance.