Vietnam requirement of CE mark for medical devices

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Sicco

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#2
They need legalization of EC certificate for registration, but I am not sure if they required physical attachment of label with CE mark.
 

Sicco

Involved In Discussions
#5
For device import you need to do local registration with TFDA agency. There are different classes for devices. Classification is really different from systems used in EU, AUS, US...
You need legalised FSC from country of device's origin (legal manufacturer) and if you have different manufacturing sites you need addresses of these sites on FSC too, and you have to prepare whole special Technical file for registration in TH which you have to discuss personally with TFDA officer - there is no form of on-line submission. But again "physical" presence of CE mark on labelling is disputable and I prefer not to state CE mark on devices intended for non-EU markets.
 
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