well nothing stopped RHY to manufacture it in EU in first place...

well nothing stopped RHY to manufacture it in EU in first place and get reimbursement approvals so this TGA dumb restriction are an excuse on why they didn't try EU first ... in my opinion..> !

OSL is a classic example and contrary to what you saying here .. .OSL has CE marking, Spain where they got some devices sold, they got approval for trials in Germany but so far no success in UK or reimbursement approvals in UK .. so whatever you have written may not correct on absolute term in my opinion... !! what i don't know is where geographically OSL devices are built so they could be built in Germany or Spain or UK and company is listed on ASX.

OSL has withdrawn their TGA application so they do not have TGA approvals even though trials were carried out in Australia !

so I don't believe that RHY simply went to TGA so they can start selling EU !

note - i sold OSL with heavy loss so not doing cross marketing at all ... just giving example on company can sell in EU even without TGA approval or at-least someone is doing that for sure in my opinion.