Hi there,
I am wondering if there are any countries which do not need a FSC (Free sales certificate) for registering products of medical device class IIb (European classification).
In addition I would like to know, whether there are countries that do not require a CE mark on the product even if it is manufactured in the EU. Meaning the manufacturer produces the product in the EU but has its products not registered there. Would it be possible to register the products in other countries and could you name some?
Thanks for your help!
I am wondering if there are any countries which do not need a FSC (Free sales certificate) for registering products of medical device class IIb (European classification).
In addition I would like to know, whether there are countries that do not require a CE mark on the product even if it is manufactured in the EU. Meaning the manufacturer produces the product in the EU but has its products not registered there. Would it be possible to register the products in other countries and could you name some?
Thanks for your help!