C'mon cafa...
CE marking is a 45 day process and IDE a 30 day process...
If you can't get approval for either in 10 years of trying and constant 'in the near future' comments, then chances are you are NEVER going to get it.
OSL has been rejected time and time again, expecting a different result is lunacy!
Ann: OncoSil Medical CE Mark Update, page-69
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