998 Canton Road, Kowloon, Hong Kong
In China, there are two major type of Face Mask- 3 ply Face Mask and KN95 Face Mask. The EU Medical Device Directive /Medical Device Regulation and Personal Protective Equipment Regulation control and regulate the import and sales of Face Mask in Europe. The below table show the different regulations between China Regulation and EU …
Steps Guide to import China KN95 Face Mask to EU Countries Read More »
CE Mark registration
If the medical device is manufactured in the EU country, the manufacturer can apply directly to the local government agency (Competent Authority). If the medical device is manufacture outside of EU, the EU authorized Representative assists the manufacturer to apply CE Registration.
Application for CE Mark registration process
1) Determine the relevant directives and harmonized standards and other requirements that the product complies with
2) Determine whether product classification requires third-party organization to participate in verification
3) Prepare Technical Files required by the preliminary directive
4) European Union Authorised Representative (Europe Union Authorised Representative) to register the local medical equipment government department
5) Affix the CE mark on your product and make an EC Declaration of conformity