Note regarding the tool 'What classification is my medical device?'
It is important to ensure that your medical device or IVD medical device has been correctly classified by the manufacturer according to Australian classification rules before you make, and pay for, an application for inclusion.
Australian classification can be different from other comparable overseas regulator's classification rules and the TGA will not refund your application fee if you submit, and pay for, an application for the incorrect classification for your device.
This tool is for guidance only for medical devices. Currently a classification tool is not available for IVD medical devices. Medical devices, including in vitro diagnostics (IVD) are classified according to the level of harm they may pose to users or patients. The higher classification level, the tougher the requirements will be.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.