Original Title: Chinese Standard KN95 Mask Obtained Conditional Access from US FDA! Be sure to pay attention to the "FDA Registration Certificate" when delivering the goods! Article Source: Ningbo Shipping, Customs Service Junior 2, Souhang.com 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. FDA has excluded the KN95 masks of Chinese standards from the scope of EUA authorization, and this newly issued document marks that the KN95 masks produced according to Chinese standards have been officially recognized by the United States. At the same time, two Chinese enterprises approved so far were announced (the list was updated dynamically). FDA official document link: Expand the full text Pay attention to the caption at the end of the figure above There are three principles for obtaining EUA authorization for masks produced in China: 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. Note: If this principle is met, manufacturers of masks designed and certified according to Chinese standards can obtain EUA authorization. 6 Manufacturers of respirators designed and validated according to China’s standards are eligible for authorization if this criterion is met. The FDA made the most crucial point with a footnote in very small print. Chinese manufacturers can submit different application materials according to these three principles. The list of application materials to be submitted is as follows: 01 If the first principle mentioned above is met, the following materials shall be submitted: The manufacturer's name, model number, and NIOSH approval number of the NIOSH approved respirator; A copy of the respirator manufacturer's name, address, model number, and product label; The number of respirators expected to be imported in a public health emergency. 02 If the second principle mentioned above is met,KN95 Face Mask with Five Layers, 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 authorisation documents/certificates issued by other regulatory bodies or conformity assessment bodies (including authorisation numbers and the name of the conformity assessment body); Certificates of compliance with applicable standards; The number of respirators expected to be imported in a public health emergency. 03 If the third principle mentioned above is met, the following materials shall be submitted: The manufacturer's name,KN95 Face Mask, address, model number, and a copy of the product label of the respirator for which authorization is sought; The name of the testing agency; Certificates 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. There are 2 manufacturers of non-NIOSH certified respirators manufactured in China approved by FDA on April 3, 2020, and the specific models are as follows: FDA Authorized Enterprise Link (the list of authorized enterprises will be updated continuously): https://www.fda.gov/media/136663/download All "FDA registration certificates" are not officially issued! The US Food and Drug Administration (FDA) recently issued an announcement entitled "Device Registration and Listing" on its official website, emphasizing that: 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. FDA will not issue registration certificates to medical device enterprises, nor will it issue confirmation certificates to registered or listed products or enterprises. Business registration and product listing information does not mean that the FDA has approved the business and its products. Many friends are confused about FDA certification, FDA registration and FDA testing, and it is easy to confuse them, so we will start to introduce them, KN95 Mask with Fast Shipping ,Full Body Disposable Coverall, hoping that you have a basic understanding and understanding. FDA Registration and FDA Testing and FDA Certification What's the difference between the three? Formally speaking, there is no FDA certification, which generally has the following three names: 1. FDA approval, which is generally aimed at more drugs, is to allow this drug to go on the market; 2. FDA registration, which appeared in the past, means that products should be registered on the FDA official website first, and some products need to be tested; 3. FDA testing, which is based on FDA's published regulations to see if the product meets the requirements of FDA regulations, is done by a third party, and FDA itself does not do any testing. They are mainly responsible for formulating regulations and market supervision. FDA testing is for materials in direct or indirect contact with food, including food containers, packaging materials, kitchen utensils, etc., collectively referred to as food contact materials. The food safety problems caused by it have attracted more and more attention from all walks of life. Testing of food contact materials is also referred to as "food grade testing.". According to the regulations and standards of the United States, it is FDA testing. The above three are generally called FDA certification in China. The FDA certification often refers to the FDA registration number. After FDA registration, there will be a registration number, which needs to be used for customs clearance. The FDA only recognizes this registration number. The FDA certificate is usually a form provided by a third-party organization for customers, not officially issued by the FDA. So what about FDA registration, which is of great concern to the industry? Question 1: Which agency issued the FDA certificate? Answer: There is no certificate for FDA registration. If the product is registered with FDA, the registration number will be obtained. FDA will give the applicant a reply letter (with the signature of the FDA Administrator), but there is no FDA certificate. FDA issued such a notice at this time is a strong reminder! Due to the recent development of the epidemic situation in the United States, the demand for medical epidemic prevention supplies exported to the United States has increased substantially, and the demand for export registration has also increased. However, some enterprises pretend to be FDA to issue certificates to manufacturers, and some distributors may get fake "FDA certificates" when consulting manufacturers. Question 2: Does the FDA require a designated accredited laboratory for testing? A: The FDA is an enforcement agency, not a service agency. If someone says that they are a certified laboratory under the FDA, then he is at least misleading consumers, because the FDA has neither a service certification body and laboratory for the public, nor a so-called "designated laboratory". FDA, as a federal law enforcement agency,Against Bacteria Breathable KN95 Face Mask, can not engage in this kind of work as both a referee and an athlete. FDA will only recognize the GMP quality of service testing laboratories and issue certificates to qualified ones, but will not "designate" or recommend a specific one or several to the public. Question 3: Is it necessary to have an American agent for FDA registration? A: Yes, a company must appoint a U.S. citizen (company/corporation) as its agent for FDA registration. The agent is responsible for process services located in the United States and is the intermediary between FDA and the applicant. Return to Sohu to see more Responsible Editor:. zjyuan-group.com

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