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
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
Why need to conduct ISO Internal Audit ? Nowadays many business are facing more competition. Many business want to make sure excellence in our business to maintain customer satisfaction and reduce cost by improvement operation. That’s why many company want to get ISO Certification.It give customer confidence and reinforce internal operation. But how do we know
One big of their Client requested RaisePrint to get FSC Certification and provide FSC Certified printed packaging for coming order. If RaisePrint could not get FSC Certificate, they may lose this client and a certain sales volume. They had no idea about FSC Certification how to comply and apply.
Recently, We ave received many enquired about ISO 14644 and ISO 13485 certification for the production of masks. What is ISO The full name is an international standardization organization. ISO has formulated more than 10,000 international standards including technical guidances testing standards and management system standards. Around 20 management system standards can be used for