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Class IIb
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Based on your selections, the classification of your medical device is Class IIb.*
*Exception - Sterile saline eye irrigation solutions intended to act on the surface of the eye to flush the eye of irritating particulates/chemicals will remain classified as Class I sterile medical devices.
About Class IIb
Class IIb devices are considered to be of moderate-high 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 may 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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