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Dear all,
could someone of you tell me if MDSAP is required to be fulfilled if a legal manufacturer is only interested in reaching the Australian Market and (currently) no other markets included into the MDSAP program?
It is about a class II medical devices which are already registered in the EU (here: class IIa).
So far, I know that the legal manufacturer does not need to own an MDSAP certificate in this case for Australia. However, I do not know if MDSAP needs to be fulfilled anyhow (independently on a certificate).
I am a little confused about the information given by the TGA regarding this topic:
Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs) | Therapeutic Goods Administration (TGA)From my understanding MDSAP is only useful (/required) if it is planned to register at least in two countries which are included into the MDSAP program (Australia, Canada, USA, Brazil, Japan).
Of course for some MDSAP countries, MDSAP requirements need to be fulfilled anyhow, e.g. for Brazil and Canada.
For Australia I could not identify if MDSAP needs to be fulfilled in general (like for Canada or Brazil).
Thank you very much for your answers in advance!