US FDA 510k Australia TGA

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Hi all,

I would like to ask you if you can help me on the following.

A company has recieved a 510k for a product in the US and has a 13485 QMS certification but NOT under MDSAP scope.

The company wants to register this product in australia.

Could you help me on which are the next steps to follow to recieve TGA approval? My understanding is that TGA only recognizes conformity assessment for devies certified by EU NB (under MDD or MDR) and those certified by the FDA (and japan, canada, brazil, etc) if the QMS has been certified under the MDSAP scope. Is this correct?

thanks a lot in advance for the help!!!

Best
J
 
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