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Originally published as All "FDA registration certificates" are fake! KN95 mask is officially recognized by the United States As of the afternoon of April 5, local time, the number of confirmed cases of COVID-19 in the United States exceeded 330,000, with 9,458 deaths. Among them, New York State has more than 120000 confirmed cases and more than 4000 deaths, accounting for more than one third of the confirmed cases and deaths of COVID-19 in the United States. FDA Announces: All "FDA Registration Certificates" Are Forged Influenced by the rapid spread of the epidemic in the United States, the "resumption of creation of shipments on April 5" expected by domestic Amazon sellers did not happen. Yesterday, many sellers squatted in the background and found that they still could not build warehouses, but some of the individual categories such as industry could be replenished, and sellers speculated that some categories were gradually liberalized. Although there was no good news to resume warehousing, another major news yesterday shocked foreign traders. A few days ago, the Ministry of Commerce and other three departments issued a notice saying that from April 1, the export of five categories of medical materials, including the new coronavirus virus testing reagent, should meet the quality standards of importing countries (regions). Just as the merchants exporting to the United States were trying to obtain FDA permission, the FDA (Food and Drug Administration of the United States) suddenly issued a notice yesterday, saying that all the FDA registration certificates on the market were fake, which stunned the merchants who were busy handling all kinds of certificates. FDA does not issue Registration Certificates to medical device establishments. FDA does not certify registration and listing information for firms that have registered and listed. Registration and Listing does not denote approval or clearance of a firm or their devices. Expand the full text The FDA does not issue registration certificates to medical device agencies. FDA does not certify the registration and listing information of companies that are already registered and listed. Registration and listing does not imply approval or licensing of the Company or its equipment. According to the industry organization, there is no certificate for FDA registration. A product registered with the FDA will obtain a registration number. The FDA will give the applicant a reply letter (with the signature of the FDA Administrator), but there is no FDA certificate. Industry insiders said that the FDA certification in China generally refers to FDA approval, FDA registration and FDA testing,Antivirus Disposable Mask with CE Certificate, while the FDA certification often refers to the FDA registration number, which is also recognized by the FDA, and the FDA certificate is usually a form provided by a third party organization for customers, not officially issued by the FDA. Sellers need to note that the only authoritative way to confirm whether a product has been listed or registered by FDA is through the FDA official website. To this one big Oolong incident, the businessman expresses: "Our FDA does not have certificate namely, have card number only, a lot of people ask why but we also do not understand, understood eventually now.". But the concept of FDA certificate has been deeply rooted in the hearts of the people. A businessman complained: "The most embarrassing thing is that domestic bidding should provide FDA certificate (plus points), explaining that there is no certificate, only online screenshots to prove that it has been certified, the other side replied: others have provided certificates, CE Certificate KN95 Mask ,KN95 Mask with Fast Shipping, you can't do this!" It makes people speechless. China's standard KN95 mask is officially recognized by the United States. At the same time as announcing the lack of certification, another FDA document raised concerns about cross-border sellers. On April 3, the FDA of the United States published on its official website a document on EUA authorization for respirators (masks) produced in China that have not been certified by NIOSH. This newly released document marks the official approval of KN95 masks produced in accordance with Chinese standards by the United States. According to the Customs Hotline of the 12360, the three principles for obtaining EUA authorization for masks produced in China are as follows: 1. Owned by one or more For manufacturers of NIOSH certified products, FDA may verify other models of filtering facepiece respirators (FFRs) manufactured in accordance with the applicable licensing standards in other countries; 2. Authorized by regions other than China ? FDA can verify; 3. Test report issued by an independent testing laboratory ? FDA may verify that the performance of the product is in compliance with applicable test standards. (Manufacturers of masks designed and validated according to Chinese standards can obtain EUA authorization if this principle is met.) Chinese manufacturers can submit different application materials according to these three principles. The list of application materials to be submitted is as follows: If the first principle mentioned above is met, the following materials shall be submitted: — — Manufacturer's name, model and NIOSH approval number of NIOSH approved respirator; -The manufacturer's name, address, model number, and a copy of the product label of the respirator for which authorization is sought; -The number of respirators expected to be imported in a public health emergency. If the second principle mentioned above is met, the following materials shall be submitted: -The manufacturer's name, address, model number, and a copy of the product label of the respirator for which authorization is sought; — — marketing authorization documents/certificates issued by other regulatory bodies or conformity assessment bodies (including authorization numbers and names of conformity assessment bodies); -Certificate of compliance with applicable standards; -The number of respirators expected to be imported in a public health emergency. If the third principle mentioned above is met, the following materials shall be submitted: -The manufacturer's name, address, model number, and a copy of the product label of the respirator for which authorization is sought; -Name of the testing agency; -Certificate of compliance with applicable standards; -The test report shows that it meets the applicable performance standards; — The number of respirators expected to be imported in a public health emergency. It is worth noting that the FDA has excluded the Chinese standard KN95 mask from the scope of EUA authorization. According to the previous news, there is a shortage of medical equipment in the United States, and the FDA has lifted the ban on the use of Chinese KN95 masks. Although the Centers for Disease Control and Prevention (CDC) lists the KN95 mask as an alternative to other certified masks in an emergency, the FDA does not have an EUA-authorized model of the KN95 mask made in China. This means that people who use such masks will not be protected by law. Therefore, the US FDA's EUA authorization on April 3 is very important. The official recognition shows that the quality of KN95 masks made in China has passed the standard, and the Chinese standard should have been recognized. With the further spread of the epidemic abroad, masks and other epidemic prevention materials are in short supply. With the official approval of the United States, Chinese mask exporters will ship more smoothly. Some netizens said that the manufacturers exporting masks are going to make money crazily! Ministry of Commerce: China will not restrict the export of medical supplies Matters related to the export of medical supplies such as masks have been affecting the nerves of cross-border sellers. Yesterday, the Joint Prevention and Control Mechanism of the State Council held a press conference. At the meeting, Jiang Fan, a first-level inspector of the Foreign Trade Department of the Ministry of Commerce, stressed that China has not and will not restrict the export of medical supplies. Jiang Fan disclosed that at present, there are more than 2,000 medical device manufacturers that have obtained the product registration certificate approved by China's drug supervision and administration department. For foreign purchasers, the number of suppliers available is relatively sufficient, and the quality of supply is more guaranteed. According to statistics, since March 1, China's customs has released major epidemic prevention and control materials for export, including about 3.86 billion masks; 37.52 million protective suit; 2.41 million infrared thermometers; 16,000 ventilators; 2.84 million boxes of new coronavirus detection reagents, and 8.41 million pairs of goggles. At present,free shipping disposable coverall, a series of news is good for businesses exporting epidemic prevention materials such as masks and protective suit, but epidemic prevention materials are a matter of life, so exporters should remember to control the quality and not smash the brand of Made in China. Source: Yien Return to Sohu to see more Responsible Editor:. zjyuan-group.com

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