TGA Classification Tool for Medical Devices and IVDs

The Australian Therapeutic Goods Administration (TGA) has released an online classification tool to help medical device and IVD manufacturers classify their devices. 

How does the TGA online medical device classification tool help manufacturers? 

In Australia, medical devices have 5 groups of classification: A to E. They are classified in relation to the level of harm they pose to users or patients. IVD devices have separate classification rules. If it is proving difficult to place your medical device in these pre-defined groups, there is an option to click ‘none of the above’ and answer more questions within the tool to help classification with TGA. These questions assess the risk of the device (for example, is the device invasive or non-invasive?). 

You can read more and access the tool on the TGA website here. 

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If you need help understanding the TGA’s latest update or classifying your medical device or IVD for the Australian market, don’t hesitate to contact us so our expert regulatory team can assist you. 

Learn how MedEnvoy can help you:

• • Australian TGA Sponsor
  • RA Consulting
  • QA Consulting