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Hello all!
We want to import medical devices class I, but they give us Compliance report and strange declaration of conformity . There is no CE marking.The factory is in China.
We are importing class IIA medical devices from China which are CE marked and with CE and Declaration of conformity looking normal.
The chinese say that they have import in EU countries and that it is so with MD class I.
We have never imported MD class I.
Any help will be heartly appreciated.
We want to import medical devices class I, but they give us Compliance report and strange declaration of conformity . There is no CE marking.The factory is in China.
We are importing class IIA medical devices from China which are CE marked and with CE and Declaration of conformity looking normal.
The chinese say that they have import in EU countries and that it is so with MD class I.
We have never imported MD class I.
Any help will be heartly appreciated.