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  • 1.  Medical Device Risk classification Tool

    Posted 01-Dec-2017 17:15

    ​Hi Guys,

    I found this very useful Medical Device Risk classification tool on HSA website.
    Medical Devices Risk Classification Tool | HSA | Health Sciences Authority

    Hsa remove preview
    Medical Devices Risk Classification Tool | HSA | Health Sciences Authority
    The above classification tool is intended to provide general guidance only. Although we have tried to ensure that the information contained here is accurate, we do not, however, warrant its accuracy or completeness. The Health Sciences Authority (HSA) accepts no liability for any errors or omissions in this tool, or for any action/decision taken or not taken as a result of using this tool.
    View this on Hsa >


    Does any other authority provides a similar tool? If yes, Can you share the link?

    Thanks,
    Meenakshi



  • 2.  RE: Medical Device Risk classification Tool

    Posted 01-Dec-2017 17:23
    ​Found another helpful tool on TGA website

    What classification is my medical device
    Therapeutic Goods Administration (TGA) remove preview
    What classification is my medical device
    Medical devices are are classified according to the level of harm they may pose to users or patients. The following tool will assist in determining the classification of a medical device that is not an In Vitro Diagnostic device. There are separate classification rules for IVD devices.
    View this on Therapeutic Goods Administration (TGA) >



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    Meenakshi

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  • 3.  RE: Medical Device Risk classification Tool

    Posted 04-Dec-2017 06:49
    Thanks for sharing! These look useful.

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    Saliane Anderssen

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