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EU CE Mark Validity in Non EU countries - Brazil. Taiwan, China, Japan, Mexico

J

jaskosk

#1
Dear friends,
Hello.
I hope that someone will help me.
We produce one dental gel which in Korea is registered as cosmetic.
We succeed to register the gel in Europe as medical device in class 1.
Please, could You tell me in which countries we can use the free sales certificate obtained in europe ?
where the ec medical directive (ce mark) is recognized?
I know for Israel and Australia?
I do not know whether this CE mark can be accetable for Brazil. Taiwan, China, Japan, Mexico?

Also, is obligatory for the laboratories where we need to conduct biological test for medical device registration to be iso accredited ?

thanks in advanced for any comment and help from your side,

best regards
 
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