As of recent, the TGA was the only Notified Body that can issue Conformity Assessments (CA) for Australian medical device manufacturers (intended to be sold in Australia). Finally, there has been a paradigm shift whereby the TGA will now accept conformity assessments from 3rd party Notified Bodies.  It will take a few months however for the Government policy approval to take place and for the changes to come into effect, but what the Australian medical device industry has been pushing for for quite some time now has finally come to fruition. For Conformity Assessment quotations, please contact Compliance Management Solutions.   About CMS: Compliance Management Solutions is an Australian based consultancy assisting organizations … Continue reading TGA – Medical Device Conformity Assessments