Ann: Update on Australian Adult Study and FDA De Novo Submission, page-69

I put a google search type address to the Emergo international timeline map a few days ago.
Gave 2-3 months on a class 2a TGA timeline, also shows USA and EU amongst others. Worth a look.
You or someone else can post the direct link if you wish. ( just weary of copyright myself)

Just search
“Compare the time, cost and complexity of getting regulatory approval for medical devices”

Should take you there


Not investment advice, do your own research, and consult a licensed adviser