Medical & Non-Medical Masks For Export
COVID-19 made us realize the importance of masks. We know a little of medical masks and non-medical masks. However, there are many standards for exporting abroad, which are different in each country. Medical masks are subject to different standards and certification requirements in different countries/regions.
Enterprises and individuals can distinguish according to the country/region where the product is imported and the applicable standards of the product. The applicable standards and certification information of the product can be provided from the outer packaging of the product or the manufacturer or obtain the test report or certificate.
Export to the U.S.
Medical masks are medical devices in the United States. They are subject to the "Medical Mask Material Performance Standard Specification" (ASTM F2100) and are managed by the U.S. Food and Drug Administration (FDA). They must pass 501K registration or other channels announced by the FDA recently to obtain factory registration and Medical devices can only be listed in the United States after they are listed. Therefore, masks exported to the United States on the outer packaging or test reports or certificates with the above content can be judged as medical masks.
The export of non-medical masks to the United States does not fall within the scope of Announcement No. 5 of 2020, but companies should note that products must be registered with NIOSH before they can be marketed in the United States.
Export to EU
EU medical/non-medical masks need to be affixed with the CE mark, but the applicable standards are different.
Medical masks are classified as Class I devices in the European Union. They are classified into Class I non-sterile and sterile. They need to be affixed with CE in accordance with EU Medical Device Directive 93/42/EEC (MDD) or EU Medical Device Regulation EU2017/745 (MDR) The mark, the corresponding standard is EN14683, and the masks exported to the European Union with the above content on the outer packaging or test reports or certificates can be judged as medical masks.
Cover companies only need to make a CE self-conformity declaration, and do not need to pass the certification of the notified body. After preparing the corresponding documents and test reports, you can complete the declaration of conformity by yourself. Sterile medical masks must also be CE certified by an authorized notification agency.
Non-medical masks exported to the European Union are not medical devices, but they must meet the requirements of the EU Personal Protective Equipment Regulation EU2016/425 (PPE). The authorized notice agency will carry out CE certification and issue a certificate. The corresponding standard is EN149.
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