Ann: Update on Australian Adult Study and FDA De Novo Submission, page-63

@silverfox3731 I remember you asked question to this forum not so long ago relating to TGA approval - timelines etc. I don't recall if anybody got back to you...

I believe this will get you drooling from the mouth -

Around 95% of devices approved in Australia are approved based on the presentation of a CE certificate."

https://brandwoodbiomedical.com/aus...us-canadian-and-japanese-approvals-with-mdsa/

This especially applies to low risk medical devices such as RAP's technology as it is non-invasive.

So if we obtain CE certification (should get an answer very soon now) then we will be granted TGA certification in a timely manner....

Cheers

Red bar