Original title: New mask CE certificate to be reported! There is other news.. With the increasing export volume of epidemic prevention products such as masks and protective suit, some individuals or organizations, for the purpose of making profits, publish information such as "CE certification can be handled quickly" through network platforms and short messages, and induce enterprises to entrust their agents with so-called "CE certification certificates" which are actually invalid or unnecessary, and charge high fees for them. It has seriously disrupted the order of the certification market. If consumers have doubts about the list of notified bodies of CE and the scope of their authorization, It can be confirmed directly through the official inquiry path https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main of the European Union. After that, is it possible to query the CE certificate through the relevant platform of the Accreditation and Supervision Commission? Look at: The Accreditation and Supervision Commission has issued a notice on the requirements for certification activities in the field of epidemic prevention supplies such as masks and protective suit. If the certified enterprise is a manufacturer of epidemic prevention supplies such as masks and protective suit, the certification body shall, within 3 days from the date of receipt of this notice, pass the product certification and management system of the "Unified Reporting Platform for Certification and Accreditation Business Information". Add and submit the relevant information of valid CE certificate and management system certification certificate, and update it at any time. Notice of the CNCA on the Relevant Requirements for the Certification Activities in the Field of Epidemic Prevention Supplies such as Masks and protective suit. Guo Ren Jian [2020] No.2 Each certification body: In order to implement the decision-making and deployment of the CPC Central Committee and the State Council on epidemic prevention and control, especially on strengthening the quality supervision of export epidemic prevention materials, according to the requirements of the Circular of the General Administration of Market Supervision on Special Rectification Actions for Certification Activities in the Field of Epidemic Prevention Supplies such as Masks and protective suit (No.54, 2020), all certification bodies should be fully implemented. Around the certification activities carried out in the field of masks, protective suit and other epidemic prevention supplies, we should carry out the traceability of the certification process, strictly implement the requirements of rules and procedures,Medical Full Body Coverall, strengthen the follow-up inspection of certifi cated enterprises, and effectively enhance the effectiveness of certification implementation. The relevant matters are hereby notified as follows: 1. Public certification information. The certification activities carried out by the agency in the field of epidemic prevention supplies such as masks and protective suit should be sorted out in detail to ensure that the relevant certification rules, work processes, charging standards and other information are disclosed in accordance with the requirements; timely response to the demands of enterprises; Conformity assessment activities (CE, etc.) involving the export of products shall truthfully inform the enterprise whether the relevant certification is a mandatory requirement for foreign market access, and shall be clearly stated in the certification entrustment contract, and shall not mislead the enterprise to carry out certification. 2. Certificate of self-examination and certification. Self-inspection should be carried out on the certification certificates issued by the agency in the field of masks,Quickly Delivery Disposable Protective Clothing, protective suit and other epidemic prevention supplies, focusing on tracking and checking whether the certified enterprises and products continue to meet the certification requirements, so as to ensure that the certification is carried out in strict accordance with the requirements of laws, regulations and procedures. 3. Strictly control the quality of certification. Certification activities in the field of epidemic prevention supplies such as masks and protective suit should be carried out under the requirements of national laws and regulations and relevant policies for epidemic prevention and control, and enterprises should be urged to strengthen the whole process of quality management by means of certification. It is necessary to continue to increase investment in certification technology, strictly control the internal quality requirements of certification agencies, clarify the responsibilities of each link of certification, and ensure the effective implementation of certification activities. Fourth, do a good job in certification services. Provide high-quality certification services to enterprises of epidemic prevention supplies such as masks and protective suit, and deliver accurate information on domestic and foreign access requirements, quality standards and certification requirements of epidemic prevention supplies to enterprises; guide enterprises to strictly implement relevant requirements and improve the quality of their products; strictly prohibit false propaganda and driving up the certification price; Certification bodies that have been approved and have the business subcontracting qualification of EU CE notified bodies shall strengthen communication and coordination with overseas notified bodies to improve the efficiency of issuing export certificates. Certification bodies that carry out product and management system certification activities in the field of epidemic prevention supplies such as masks and protective suit should submit the relevant information of certification certificates on the "Unified Reporting Platform for Certification and Accreditation Business Information" (website: report. Cnca. CN) in accordance with the requirements (see annex). If the certification bodies encounter problems such as policy understanding in carrying out relevant certification activities, please report them to the CNCA in a timely manner. Expand the full text CNCA April 13, 2020 Enclosure Contents to be submitted for certification information of epidemic prevention supplies If the certified enterprise is a manufacturer of epidemic prevention supplies such as masks and protective suit, Antivirus Disposable Mask with CE Certificate ,Virus Prevention Mask 3 Ply with Earloop, the certification body shall, within 3 days from the date of receipt of this notice, report the certificate information through the product certification, management system and service certification function menu of the "Unified Reporting Platform for Certification and Accreditation Business Information" (website: report. Cnca. CN, hereinafter referred to as the Reporting Platform). Add and submit the relevant information of valid CE certificate and management system certification certificate, and update it at any time. Specific requirements are as follows: I. CE Certificate (I) Fill in B0598 for the item classification code of CE certificate. (II) The classification of epidemic prevention products with CE certificate shall be filled in according to the Classification Code of Epidemic Prevention Products, and multiple codes shall be separated by a full-width semicolon ";". (3) The main items such as the name of the CE certified enterprise, the notified body and its number, the date of issuance, the validity period (if any), the name of the certified product, the name in accordance with EU directives or regulations, and the status of the certificate (valid, suspended, revoked or cancelled) shall be translated into Chinese and submitted. II. Management System Certification The classification of epidemic prevention products produced by the certified enterprise shall be filled in according to the Classification Code of Epidemic Prevention Products, and multiple codes shall be separated by a full-width semicolon ";". III. Classification Code of Epidemic Prevention Products Other certificate information fields of CE certificate and management system certification certificate shall be submitted in accordance with the Information Reporting Specification for Voluntary Industrial Product Certification of Certification Bodies and the Information Reporting Specification for Management System Certification and Service Certification of Certification Bodies (which can be downloaded from the reporting platform). Latest and more news about epidemic prevention supplies Seriously affect the national image! Ministry of Commerce Stops Two Companies from Exporting Epidemic Prevention Supplies On April 13, the Ministry of Commerce issued a circular announcing the suspension of the export of epidemic prevention supplies by the two companies. The full text is as follows: Circular on Stopping the Export of Epidemic Prevention Supplies of Two Companies In the process of carrying out the export of epidemic prevention supplies, some enterprises were returned by foreign parties due to product quality problems, which disrupted the export order of epidemic prevention supplies and seriously affected the national image. Now stop the export of epidemic prevention supplies of Beijing Qidi Block Chain Technology Development Co., Ltd. and Aibaoda Technology (Shenzhen) Co., Ltd. Working mechanism for commercial export of medical supplies April 13, 2020 FDA urgently authorized a large number of KN95 masks from Chinese enterprises On April 11, an updated document on the website of the FDA (Food and Drug Administration of the United States) showed that 46 mask manufacturers with factories in China had received emergency use authorization (EUA). Except 3m China, Creative Concepts and other foreign-funded enterprises, the rest of the enterprises are manufacturers all over China, including Guangdong, Shandong, Henan, Sichuan, Jiangsu and other places. Among the enterprises that have obtained emergency authorization, 26 have used China's KN95 standard to produce masks. According to FDA documents, masks produced in China need to meet three requirements to obtain EUA authorization: First, manufacturers with one or more NIOSH (National Institute for Occupational Safety and Health) certified products can produce other types of filtering facepiece respirators (FFR) in accordance with the applicable authorization standards of other countries/regions, which can be verified by FDA; Second, if it is authorized by other regions outside China, FDA can verify it; third, if there is a test report issued by an independent testing laboratory, which can show that its product performance conforms to the applicable test standard, FDA can verify it. It is reported that KN95 mask is a kind of mask with particulate matter filtration efficiency in line with China's national standard, which is a compulsory national standard in China and proposed by the State Administration of Work Safety. From the perspective of scope of application, this standard is applicable to ordinary self-priming filter-type respiratory protective equipment for protecting various particles. N95 refers to one of the nine particulate protective masks certified by NIOSH (National Institute for Occupational Safety and Health). Generally speaking, KN95 masks and N95 mask have roughly the same particulate matter filtration efficiency. It is reported that the FDA has excluded the Chinese standard KN95 masks from the scope of authorization. This newly issued document marks that the KN95 masks produced according to the Chinese standard have been officially approved by the US regulatory authorities. Comprehensive sources: CNCA,KN95 Face Mask, The Paper, China Economic Net, etc. Disclaimer: This account is a personal account and does not represent the opinions of any unit. Return to Sohu to see more. Responsible Editor:. zjyuan-group.com
