Australian Medical Device Database like the US FDA's 510(k)

C

cannycheng

#1
Dear All,

I have one diposable product need to register in Aus, would anybody can help me,whether the Aus FDA database like the US FDA 510(K)?
Thank you:thanks:
 
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Ajit Basrur

Staff member
Admin
#2
Dear All,

I have one diposable product need to register in Aus, would anybody can help me,whether the Aus FDA database like the US FDA 510(K)?
Thank you:thanks:
Hi cannycheng,

Welcome to the Cove :bigwave:

The Australina equivalent of the FDA is called Therapeutic Goods Adminitsration (TGA) and if you refer this, there is an entire section on medical devices.

If you refer the section on Medical Devices : Manufacturers , refer to the section - Getting things done. This section will tell you all the required tasks for getting the device into the market.
 
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