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.
ISO 13485 is a quality management system standard for medical devices, which comes from the ISO 9001 quality management system standard. ISO 13485 ensures that manufacturers continue to design, develop, produce, install and deliver safely and in compliance with relevant regulatory requirements and the intended purpose of medical devices.