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Original title: The CE certificates issued by these organizations are all fake! Source: GMP data sharing group With the increasing export volume of epidemic prevention products such as masks and protective suit, market supervision departments have found that some individuals and organizations, for the purpose of making profits, have issued information such as "handling CE certification" to induce enterprises to entrust their agents with so-called "CE certification certificates" which are actually invalid or unnecessary, and to charge high fees for this, which not only makes enterprises. It has seriously disrupted the order of the certification market. The National Accreditation and Supervision Commission, local market supervision bureaus and the European Union have issued notices for many times to remind enterprises to be vigilant and avoid being cheated. Today, Mike Foreign Trade said that he would integrate resources for you to let you know more clearly about the identification and processing of CE certification and the access standards of epidemic prevention materials such as masks in the European Union and the United States; I believe that after reading it, you can avoid a lot of pitfalls and spend less money. 01 Inquiry on the official website of the EU Issuing Notified Body The notified body information can be obtained from the certificate to check whether the notified body issuing the certificate has the corresponding qualifications of the European Union Medical Device Directive MDD 93/42/EEC, MDR Medical Device Regulation (EU) 2017/745 or (EU) 2016/425 Personal Protective Equipment Regulation. EU Notified Body Enquiry Address 1. European Union Medical Device Directive 93/42/EEC (MDD) authorized agency inquiry address: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13 2. European Union Medical Device Regulation EU2017/745 (MDR) authorized agency inquiry address: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 3. EU Personal Protective Equipment Regulation EU2016/425 (PPE) authorized agency inquiry address: For specific query methods, please refer to: The most detailed in history! Why your CE certificate may be false, how to distinguish between true and false, and how to handle the true CE certificate 02 CE Certification Notified Body official website inquiry After confirming that the issuing authority is the CE certification notified body authorized by the European Union, law enforcement officers can log on the official website of the notified body to check the authenticity of the certificate. In general, the notified body will have a page to check the certificate. You can enter the manufacturer's English name, certificate number and other information to check whether there is a matching CE certificate. If so, this may be a genuine certificate. In particular, it should be noted that the CE certificate can only be issued by a notified body. 03 Expand the full text Process analysis and identification for CE certification Take the mask as an example. First, confirm whether the mask is a medical device. Masks are divided into medical masks and personal protective masks, which must be exported to the EU in accordance with the relevant EU regulations: Personal protective mask Personal protective masks are not medical devices, but they are required to meet the requirements of the European Union Personal Protective Equipment Regulation EU2016/425 (PPE). The authorized notified body carries out CE certification and issues certificates. The corresponding standard is EN149. Medical mask Medical masks shall be affixed with CE mark in accordance with EU Medical Device Directive 93/42/EEC (MDD) or EU Medical Device Regulation EU2017/745 (MDR), and the corresponding standard is EN14683. According to the aseptic or non-aseptic status of mask products, the conformity assessment mode is also different. If it is a medical mask, we need to further confirm whether it is sterile.
01. If it is a sterile medical mask,Full Body Disposable Coverall, which belongs to a class I sterile medical product in the European Union, it must be certified by CE in accordance with the Medical Device Directive/Regulation MDD/MDR. In this case, an authorized notified body must be involved. 02. If it is a non-sterile medical mask, it is a CE self-declaration in accordance with the Medical Device Directive/Regulation MDD/MDR. Enterprises do not need to pass the certification of notified bodies, and can complete the declaration of conformity by themselves after preparing the corresponding documents and test reports. Personal protective suit Personal protective suit are CE certified in accordance with the European Union Personal Protective Equipment Regulation EU2016/425 (PPE). medical protective suit Medical protective suit are managed according to medical devices, in which sterile medical protective suit need to obtain CE certification according to EU Medical Device Directive 93/42/EEC (MDD) or EU Medical Device Regulation EU2017/745 (MDR). Non-sterile medical protective suit are only required to make a CE self-declaration. 04 US requirements for mask product access Medical masks and protective masks are also managed differently in the United States, with medical masks managed by the Food and Drug Administration (FDA) and personal protective masks managed by the National Institute for Occupational Safety and Health (NIOSH). 1. Medical mask Medical masks need to be registered by FDA, and enterprises apply directly to FDA's official website and submit relevant materials. In addition,KN95 Face Mask, there are two options: (1) N95 mask that have been registered by NIOSH may be exempted from product marketing registration (510K) and directly undergo FDA factory registration and medical device listing if the product passes the biological test, flame retardant test and blood penetration test. (2) If authorized by a 510K-holding manufacturer, may use its 510K approval number as its foundry for enterprise registration and device listing. 2. Personal protective mask Protective masks need to be registered through NIOSH, and enterprises can apply directly on the NIOSH official website. 05 US requirement for access to protective suit product The management of medical protective suit and personal protective suit is similar to that of masks, in which medical protective suit is managed by the Food and Drug Administration (FDA) and personal protective suit is managed by the National Institute of Occupational Safety and Health (NIOSH). Enterprises directly apply for registration with FDA or NIOSH. 06 Information Guide for Export of Masks and Other Epidemic Prevention Supplies to the European Union Example of an invalid certificate 01 CE certificate issued beyond the scope The scope of ECM announcement does not include personal protective equipment, and the certificate of personal protective mask issued is beyond the scope of issuance, and the certificate is invalid. ICR is the notified body of the European Union in the field of electrical and electronic equipment, and has no corresponding qualification in the field of medical devices and personal protective equipment, which is beyond the scope of certification, and the certificate is invalid. As a notified body of electrical and electronic equipment products, celab has no corresponding qualification in the field of medical devices and personal protective equipment, and the certificate issued beyond the scope is invalid. 02 Not a CE certificate per se Document audit certificate of the disposable Not Sterile medical mask issued by ECM to the enterprise. The document review report is not a CE certificate. The certificate issued by the EU representative of the enterprise to complete the official registration of the enterprise's products with the Netherlands is not a certificate of certification. Zoustech, the representative organization of the enterprise in Spain, gives the official registration certificate of the product in Spain, not the CE certificate. Zoustech specializes in EU representation. Note: Products exported to the EU need to be officially registered by the EU representative, which is not CE certification. 03 Invalid certificate issued by unqualified organization These institutions are not the notified bodies of the European Union, nor do they have the corresponding qualifications of the European Union Medical Device Directive MDD 93/42/EEC, Antivirus Disposable Mask with CE Certificate ,Virus Prevention Mask 3 Ply with Earloop, MDR Medical Device Directive (EU) 2017/745 or (EU) 2016/425 Personal Protective Equipment Regulations. The certificates issued in violation of the regulations are invalid.
STS is not a notified body, but a domestic testing institution for electronic and electrical products. This certificate has nothing to do with masks and is not a CE certificate. BSI TESTING is not a notified body and the certificate is invalid. TUV-world is not a notified body, and disposable non-sterile medical masks should be self-declared, without certification by the notified body, and the certificate is invalid. NPS is not a Notified Body for this product area. The certificate is not valid. CIC is not a notified body of the European Union, but a testing institution in Shenzhen, which is an invalid certificate. Amtre Veritas is not an EU Notified Body and the certificate is invalid. ENC is not a notified body of the European Union, but a testing body in Guangzhou, and the certificate is invalid. The STS is not an EU notified body and the certificate is invalid. HTT is not a notified body of the European Union, but a private enterprise in Shenzhen, and the certificate is invalid. The iTC is not a notified body of the European Union, but a testing body in Shenzhen, and the certificate is invalid. BTK is not a notified body of the European Union, but a testing institution in Guangzhou, and the certificate is invalid. Micez is not a notified body of the European Union, but a testing institution in Shanghai, and the certificate is invalid. Huawin is not a notified body of the European Union, but a testing institution in Shenzhen, and the certificate is invalid. LTT is not a notified body of the European Union, but a testing body in Shenzhen, and the certificate is invalid. The IC is not an EU notified body and the certificate is invalid. JZ-CERT is not a notified body of the European Union and the certificate is invalid. OCT is not a notified body of the European Union, but a testing institution in Guangzhou, and the certificate is invalid. ACT is not an EU notified body and the certificate is invalid. XW-CERT is not a notified body of the European Union, but a company in Shenzhen, and the certificate is invalid. ATL is not a notified body of the European Union, but a testing body in Shenzhen, and the certificate is invalid. TMC is not a notified body of the European Union, but a testing body in Shenzhen, and the certificate is invalid. Youbest is not a notified body of the European Union, but a testing body in Shenzhen, and the certificate is invalid. Shenzhen Tian Hai Test Technology is not a notified body of the European Union, but a testing organization in Shenzhen, and the certificate is invalid. The UK INSPEC INTERNATIONAL CO. LTD is not a notified body of the European Union and the certificate is invalid. The bel is not a notified body of the European Union, but a testing body in Shenzhen, and the certificate is invalid. Mosen is not a notified body of the European Union, but a testing institution in Guangzhou, and the certificate is invalid. The ZUOCE CERTIFICATION AND TESTING CENTER is a testing institution in Shanghai, not a notified body of the European Union, and the certificate is invalid. The Nimu certification service grouping is not a notified body of the European Union and the certificate is invalid. AS is a testing organization in Shenzhen, which is not a notified body of the European Union, and the certificate is invalid. JCT TESTING is a testing organization in Shenzhen, not a notified body of the European Union, and the certificate is invalid. The BSI TEST LTD is not a notified body of the European Union and the certificate is invalid. QCT is a testing organization in Guangzhou, not a notified body of the European Union, and the certificate is invalid. CCT is a testing organization in Shenzhen, not a notified body of the European Union, and the certificate is invalid. This is a testing institution in Shenzhen, which pretends to be CTC, the notified body of the European Union, and the certificate is invalid. Example of a valid certificate 1. This is a corporate self-declaration. 2. Certificate Sample of SGS-CSTC Standards Technical Services Co., Ltd. 3. British Standard Management System Certification Sample Certificate of (Beijing) Co., Ltd. 4. South German Certification Testing (China) Co.,Medical Disposable Coverall, Ltd. (T TÜV S SÜD Product Service GmbH Zertifizierstellen) Hint If consumers have doubts about the list of CE notified bodies and the scope of their authorization, they can directly confirm through the EU official website; if they find suspected violations of certification laws and regulations, they can also call the 12345 or 12315 to report to the regulatory authorities.
Attached is a list of domestic certification bodies with business qualifications such as masks of EU notified bodies: Return to Sohu to see more Responsible Editor:. zjyuan-group.com