A
anamensis
This might sound like a very silly question, but how do you determine whether a product is a medical device in Australia?
I know there?s the definition of what a medical device is, but is there a flowchart available like the ones for US FDA or for CE Mark in Europe?
I was thinking of using the Australian medical device definition and the CE mark flowchart of determining whether a product is a medical device, only because EU and Australia have Mutual Recognition Agreement (MRA) between them (but I?m not sure if it?s right for me to do so).
Currently the product I?d like to define is identified as a non-medical device product, and has CE marking.
Any help would be greatly appreciated.
Thanks,
A.B.
I know there?s the definition of what a medical device is, but is there a flowchart available like the ones for US FDA or for CE Mark in Europe?
I was thinking of using the Australian medical device definition and the CE mark flowchart of determining whether a product is a medical device, only because EU and Australia have Mutual Recognition Agreement (MRA) between them (but I?m not sure if it?s right for me to do so).
Currently the product I?d like to define is identified as a non-medical device product, and has CE marking.
Any help would be greatly appreciated.
Thanks,
A.B.