Originally published as Are you still exporting masks? Don't Step on These Nine Mistakes Disposable masks became a hot seller after the global outbreak of COVID-19 in January 2020. Medical staff should use it, related service industry personnel should use it, ordinary people should use it.. Disposable masks are in short supply. Before the outbreak of the epidemic, China produced more than 50% of the world's masks, and now it is as high as 90%, so China's masks are exported to Europe and the United States, and many manufacturers want to catch the train. However, the entry of Chinese masks into foreign markets has repeatedly caused various problems, which not only lead to economic losses, but also damage the image of Made in China. Many enterprises are raising questions about the export of masks to Europe and the United States. In fact, there are already some common misunderstandings when they ask questions. The common misunderstandings are as follows: Mistake 1: All disposable masks entering the EU market must obtain CE certification. Actually, it's not. CE certification is a conformity assessment method for products entering the EU market, which generally has two forms of self-declaration and certification body certification. In the European Union, disposable masks are divided into two categories: medical and personal protective equipment (PPE). Medical use is divided into sterile and non-sterile, and the detection standard is EN 14683:2019. Personal protection is divided into FFP1, FFP2 and FFP3, of which FFP3 has the highest protection risk level, and the test standard is EN149: 2001 + A1 2009. Their respective requirements are shown in the figure below. Expand the full text Myth 2: All Notified Bodies can certify medical masks Actually, it's not. Agencies engaged in CE certification in the European Union need to be authorized by the European Commission. On its official website, there is a list of authorized Notified Bodies (NB), and a four-digit number code corresponds to each Notified Body. Each Notified Body has its own scope of authorization for certification products, which is different. The product range of its authorized certification can be found on the official website,KN95 Face Mask, and then click in to find it. Therefore, if the masks produced by domestic enterprises need CE certification, they must find a notified body with the authorization of the corresponding product regulations, and the CE certificate issued by it is legally valid. Usually, an NB is only authorized by the European Union to carry out certification in one or several modes for one or several types of products. Whether it is to find a notified body for CE certification or a manufacturer's CE self-declaration of conformity, technical documents must be prepared, which can be prepared by the manufacturer itself or with the help of a professional organization. Domestic production enterprises must designate an EU Authorized Representative in the EU, and the representative shall go to the competent authorities of member States to register and handle relevant matters. Official website: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main Mistake 3: Medical masks must obtain CE certification Actually,KN95 Mask with Fast Shipping, it's not. The sterile mask in the medical mask must obtain the CE certificate issued by the authorized notified body, and the CE mark followed by the four-digit code of the notified body shall be printed on the product; Non-sterile masks in medical masks do not need to obtain CE certificates issued by authorized notified bodies, as long as the manufacturer carries out CE self-declaration of conformity, compiles and submits technical documents and obtains registration with the European Commission, it can enter the EU market. However, the product needs to be printed with the CE logo, which is not followed by a four-digit code. Mistake 4: The export of personal protective masks does not require CE certification. Actually, it's not. In the European Union, if a personal protective mask belongs to the FFP3 category, it must have a CE certificate issued by an authorized notified body, and the CE mark should be printed on the product, followed by the four-digit code of the notified body. If the personal protective mask is classified as FFP1 and FFP2, the manufacturer must also make a CE self-declaration of conformity and obtain registration in the European Union, and the product must also be printed with the CE mark, but there is no four-digit code behind it. Myth 5: Medical masks entering the US market require FDA certification. No. In the United States, CE Certificate KN95 Mask ,free shipping disposable coverall, medical masks are managed by the Food and Drug Administration (FDA) and regulated as Class II medical devices. Manufacturers' mask products need to be registered with the FDA rather than certified before they can enter the U.S. market. After successful registration, FDA does not issue a certificate, but only sends a reply letter signed by the FDA Administrator, that is, FDA's 501 (K) approval letter. A list of 510 (K) pre-market announcements can be found on its website: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. FDA registration is valid for one year, and overdue registration and payment need to be resubmitted. Domestic enterprises must designate a U.S. representative (authorized agent, citizen/company/corporation) when registering with FDA, who is authorized to handle all matters with FDA. Personal protective masks also require FDA certification. Actually, it's not. In the United States, personal protective equipment is not regulated by FDA, but by the Department of Labor. The Department of Labor stipulates that personal protective masks entering the U.S. market must be certified by the National Institute of Occupational Safety and Health (NIOSH). Note that NIOSH certification has certification certificates. If KN95 masks want to enter the US market, they need to obtain NIOSH certification. NIOSH certification is relatively difficult, and only a few enterprises in China have passed the certification. If the KN95 mask is to be used as a medical mask at the same time, it must be registered by FDA, that is, both NIOSH certification and FDA registration must be done. Mistake 7: Disposable flat masks must be non-medical masks, and disposable duckbill masks are medical masks. Disposable medical masks and surgical mask are flat masks, because the inner interlayer is spray melting cloth, which can play a role in blocking droplets, to a certain extent, blocking infectious substances and pollutants. Disposable duckbill masks, such as KN95 masks, are classified as personal protection, mainly for respiratory protection of particulate matter such as dust, not medical masks, and can not be used to block infectious substances and pollutants. Mistake 8: China's CNAS approved laboratories with mask testing qualification can be exported after passing the test. Actually, it's not. On April 1, 2020, the European Security Federation (ESF) issued the Statement on the Suspicious Product Certificate of Personal Protective Equipment (PPE) on its official website, involving 45 laboratories accredited by CNAS with the qualification of mask testing (China National Accreditation Committee for Conformity Assessment published on its official website on March 25, 2020). They are not among the Notified Bodies (NBs) that can issue type test certificates for EU products. In most cases, the tests carried out by the 45 laboratories mentioned above only meet Chinese standards, not EU standards. Therefore, production enterprises can not use it as a basis for export, but only as a reference. Mistake 9: Masks that have not obtained CE certificate or CE self-declaration of conformity in the process of CE certification cannot be exported to the EU market. The answer is yes. On March 13, 2020, according to the Recommendation on Conformity Assessment and Market Surveillance (EU) 2020/403 issued by the European Commission, in order to solve the shortage of masks during the epidemic, PPE and MD without CE label will be allowed to enter the EU market, and the relevant market surveillance authorities will evaluate these substances. For products that have not completed the final CE marking assessment, the EU supervision authority may allow them to be sold in the EU market, but only within a specific period of time. During the sales period, the products still need to be reviewed simultaneously. For products without CE marking, they can also be purchased by the government approval authority (only during the epidemic period). In addition, the above products can only be used by medical staff, and can not be sold in the general market or used by other personnel. Of course, getting CE certification and FDA registration can not be done once and for all. On May 7, the FDA said on its website that it had found that more than 60 Chinese-made masks were not up to standard (mainly the particulate filtration efficiency of N95 mask),Medical Full Body Coverall, so it reduced the number of Chinese mask manufacturers allowed to sell in the United States from 80 to 14. Therefore, the most important thing for the export of masks is that their quality meets the standards of the importing countries, not the Chinese standards. Return to Sohu to see more Responsible Editor:. zjyuan-group.com