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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 considered to be of low-moderate risk and 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.
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 online tool. Please contact the TGA if you require further information or assistance.