Google this below get the world timeline I think its class 2a in...

Google this below get the world timeline I think its class 2a in CE so assume same class in AU has FDA time at bottom as well
Assume all tga timeline has existing ce approval for medical devices as 97% use it as back up, therefore those numbers should be fairly accurate.

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





Also in small print on another page

The tga reserves the right to make an audit regardless of ce approval which could add time.


That’s the unknown,


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