Confirming that Colostat is classified as a Level II medical device for the purposes of TGA processing. This means that it does not need to go to the Advisory Committee for Level III devices, which only meets every 2 months, but rather a decision can be reached at any time, remembering that a decision is required within 255 working days which gives a deadline of 19th May 2023 for the Colostat application.
https://www.tga.gov.au/sites/default/files/classification-of-active-medical-devices-including-software-based-medical-devices.pdf
Confirming that Colostat is classified as a Level II medical...
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