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Original Title: US Rejects China’s KN95 Mask! The export qualification of masks is not up to standard! CE and FDA certification are indispensable Recently, the Food and Drug Administration of the United States launched a new “Emergency-Use-Administration” (EUA), which States that only six countries and regions can accept respirator products that meet the specified performance standards, compared with the previous list issued by the CDC of the United States. Only China is missing from the new table, as follows: This news has caused great concern, because in the previous “Optimizing N95 mask Supply Strategy: Crisis/Alternative Strategy” published by the United States, CDC said that during the shortage of N95 mask, it is necessary to consider suitable alternatives for N95 mask, and when the supply is insufficient, some products are expected to replace N95 mask. The following is a list of relevant national products published by CDC: Expand the full text Australia, Brazil, China, Europe, Japan, South Korea and Mexico are listed, and the acceptable product categories include China’s four mask models of KN 100, KP100, KN95 and KP95. But now the United States has temporarily changed its mind, the reasons may be very complicated, but it may have a lot to do with the recent frequent substandard products of medical supplies exported from China. Half of the masks exported to the Netherlands are not up to standard. Several Dutch media reported on March 28 that the Dutch government had recently imported a batch of masks from China,KN95 Face Mask with Five Layers, but a large part of them were found to be “unqualified”. The masks have been distributed to hospitals, and the Dutch Ministry of Health is recalling them. The total number of masks imported from the Netherlands is 1.3 million, which is used to distribute to medical workers on the front line of COVID-19 epidemic prevention. However, the 600,000 masks that have arrived have been accused of “a large number of substandard problems”, including that the masks do not fit the face properly and the filter elements do not effectively block fine particles containing viruses. Spanish test kit is only 30% accurate According to Spanish media reports such as El Pais and El Mundo, the results of a batch of new coronavirus rapid detection kits purchased by Spain from China are not accurate. According to the requirements,KN95 Face Mask, the accuracy of the kits should be more than 80%, but this batch of kits is only 30%. The Spanish government said in a statement that the defective kits were not purchased directly by the Spanish government from the Chinese government, but imported from Chinese manufacturers through a domestic supplier. As the incident coincided with Spain’s announcement that it would spend 432 million euros to buy medical supplies from China, the incident attracted great attention on Spanish social networks. Products exported overseas should meet local qualification certification. At present, the epidemic situation in foreign countries is getting worse and worse, and there is a huge gap for epidemic prevention supplies. The number of epidemic prevention supplies exported from China is also very large, and it is inevitable that dragons and snakes are mixed. Quality problems are not absolute in some cases, which to some extent include user requirements and experience problems, perhaps only the country’s testing standards are different from those of China or the European Union, which leads to such a conclusion, but there is also the possibility that some products do not meet the quality standards. Therefore, the testing and certification qualifications of various regions are particularly important, such as CE certification of the European Union, FDA certification of the United States, CE Certificate KN95 Mask ,KN95 Mask for Epidemic Prevention and Control, etc. Only products with these certifications can be exported to the corresponding countries and regions. America Necessary information (qualification) Bill of lading, packing list, invoice Personal protective mask NIOSH testing certification is required, that is, National Institute for Occupational Safety and Health certification. Medical mask It must be registered with the FDA of the United States. European Union Necessary information (qualification) Bill of lading, packing list, invoice Personal protective mask The EU standard for personal protective masks is EN149. According to the standard, masks are divided into three categories: FFP1/FFP2 and FFP3. All masks exported to the European Union must obtain CE certification.
CE certification is a compulsory product safety certification system implemented by the European Union, aiming at ensuring the safety of life and property of the people in EU countries. Medical mask The EU standard for medical masks is EN14683. Products sold in the EU need to issue the EU Free Sale Certificate. With the CE mark and the EU registration required by the relevant directives, Chinese manufacturers do not need the Free Sale Certificate to export to the EU. Japan Necessary information (qualification) Bill of lading, packing list, invoice, manufacturers outside Japan must register manufacturer information with PMDA. Mask packaging requirements The package is printed with the words (Chinese translation: virus blocking) 99%. PFE: 0.1 um particulate filtration efficiency BFE: Bacterial Filtration Rate VFE: Virus Filtering Rate Mask quality standard 1. Medical protective mask : Comply with China’s GB 19083-2010 mandatory standards, filtration efficiency ≥ 95% (using non-oily particles test). 2. N95 mask: NIOSH certification, non-oily particulate matter filtration efficiency ≥ 95%. 3. KN95 mask: It meets the mandatory standard of GB 2626 in China, and the filtration efficiency of non-oily particles is ≥ 95%. Korea Necessary information Bill of lading, packing list, invoice, Korean importer’s business license. Standard for personal protective mask KF (Korean filter) series is divided into KF80, KF94 and KF99 Implement standard specifications MFDS Notice No. 2015-69 The regulatory threshold for the access of medical devices in Korea is basically classified into Class I, II, III and IV, the License holder is a Korean company, and the Korean consignee needs to Korea Pharma ceutical Traders Association. With the Korean Food and Drug Administration. Import qualification for filing in advance Website: www. Kpta. Or. Kr. Australia Necessary information Bill of lading, packing list, invoice. Must be registered with the TGA in Australia and comply with Standard Specification AS/NZS 1716:2012, which is the Australian and New Zealand standard for respiratory protective devices. TGA is the abbreviation of Therapeutic Goods Administration, which is the supervisory body of therapeutic goods (including drugs, medical devices, genetic technology and blood products) in Australia. Medical devices in Australia are classified into Class I, Is and Im, IIa, IIb and III. The classification of products is almost the same as that of the European Union. If the product has obtained the CE mark, the product category can be classified according to CE. Professional Qualification Certification Helps Mask Export Worldwide At present, the global epidemic is spreading, and masks have become a necessity for human beings. However, when masks go abroad to various countries, they need to have corresponding qualification certification. Sikai has been rooted in the industry for 14 years, with mature and standardized enterprise service system, high standards, high quality services and innovative solutions, which are highly trusted by customers. Diversified product certification and testing certification, with excellent technical team, has successfully served more than 10000 enterprises,Medical Quickly Delivery Antivirus Coverall, covering various industries at home and abroad. With high-quality and efficient service and professional technical knowledge, Sikai consultants pave the way for the smooth global flow of customer products. If you have testing and certification needs, you can contact Sikai professional consultants in time. Return to Sohu to see more Responsible Editor:. zjyuan-group.com