Original title: Keep your eyes open: What are the common invalid/false certificates of masks? Teach you how to tell! Recently, when supervising and inspecting the certification of enterprises producing epidemic prevention products such as masks and protective suit, the market supervision department found that some enterprises issued by domestic and foreign institutions were used to obtain CE certification certificates. It is not the certification certificate of the authorized body of the European Union Medical Device (MDD 93/42/EEC Medical Device Directive, MDR (EU) 2017/745 Medical Device Regulation) and Personal Protective Equipment (PPE Regulation (EU) 2016/425), which can not be used as a valid certificate to enter the European market. I hereby warn and remind relevant enterprises that enterprises with certification needs in the field of epidemic prevention supplies such as masks and protective suit should go to institutions that can provide certification services legally and in compliance with regulations for certification, if they need policy consultation, they can consult with the market supervision department of the territory, and when their legitimate rights and interests are infringed in the process of certification, they should not. You can call the 12315 consumer complaint hotline to report to the regulatory authorities. When applying for CE certification of the European Union, the certification body approved by the Accreditation and Supervision Commission and authorized by the European Union shall be selected for certification. The list of certification bodies can be found on the website of the Accreditation and Supervision Commission. Website: http://www.cnca.gov.cn What are the common invalid certificates? Let's take a look! 1 Is the FDA registration document a certification certificate? FDA registration does not issue a certificate. The FDA registration certificate (as shown in the figure below) issued by some agencies only proves that the enterprise has completed the registration of the Food and Drug Administration of the United States. Such certificate is not a certification certificate. When encountering the so-called FDA certificate, you can inquire about the FDA registration of enterprise products through the website: https://www.accessdata.fda.gov/s/cdrh/cfdocs/cfRL/rl.cfm (Enter the English name of the enterprise in the "Owner/Operator Name" column for query, and pay attention to whether it is enterprise registration or product registration) 2 CE certificate issued by ECM Expand the full text ECM does not have the authorization of personal protective equipment regulations, and the certificates issued by it according to EN 149 are not valid CE certificates. At present, there are two main types of ECM false certificates found: 0 1 "CE Documentation Review" Certificate The figure below is a document review report of the disposable Not Sterile medical mask issued by ECM to the enterprise. Disposable non-sterile medical masks can be self-declared by enterprises without certification by the notified body of the European Union. This kind of certificate should not be recognized as a certification certificate. The document review report is not a CE certificate. It shows the CE mark, which is misleading. It is deceptive to describe it as a CE certificate. 0 2 ECM "Certificate of Compliance" See the figure below for an example. The product type is KN95 Protective Mask – FFP2,Medical Quickly Delivery Antivirus Coverall, which is a personal protective mask. Applicable standards: EN149: 2001 + AI: 2009. Personal protective equipment is not included in the scope of the agency's announcement, and all the CE certificates issued by the agency for personal protective equipment conforming to "EN149" are false certificates. Pay attention to the content in the red box. Note: 1. FFP2 respirator refers to the respirator meeting the European standard (CEEN149: 2001). 3 Is the certificate issued by ICR valid? The mask certificate issued by ICR is not a valid CE certificate! The ICR is not authorised by the EU PPE Regulation, nor by the Medical Devices Directive.
(Pay attention to the organization logo in the red box) 4 Is the certificate issued by the Shang ghai GOM Testing "valid? The issuing authority of the certificate is domestic, which cannot be the notified body of the EU Personal Protective Equipment Regulation and is not a valid CE certificate. 5 Is this RoHs certificate valid? Certificates with the word RoHs have defined themselves as certificates, but the EU RoHs Directive itself applies to electronic and electrical products, and disposable masks have nothing to do with this directive. 6 Is this certificate valid? This is a certificate issued by a consulting company in Shenzhen,Quickly Delivery Disposable Protective Clothing, which is not a notification body for personal protective equipment regulations. It is a fake certificate. 7 Is the Zoustech certificate valid? Zoustech, the representative organization of the enterprise in Spain, gives the certificate of official registration 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. 8 "BST Testing Service International Co., is the certificate issued by the Ltd." Valid? "? The agency is not a notified body (NB agency) and is not qualified to issue a CE certificate for personal protective equipment (PPE), so the certificate is invalid. 9 Is the certificate issued by TUV ? world valid? The certificate is invalid. Reason: TUV ? world is also not a notified body; medical non-sterile disposable masks should be self-declared and do not need to be certified by a notified body. Contributed by: Taizhou Market Supervision Bureau Customs teaches you to distinguish the authenticity of the mask certificate before customs declaration Masks in many countries have access conditions, many manufacturers in order to ensure that their production of masks can be exported smoothly, spend a lot of money to intermediary companies to do the relevant certification. Recently, the Customs has seized the export of medical materials that have not obtained the registration certificate of medical devices. At the same time, Antivirus Disposable Mask with CE Certificate ,Medical Full Body Coverall, export enterprises are reminded to identify the authenticity of relevant certification certificates before customs declaration so as to avoid losses. Let's learn more about how to distinguish the authenticity of the mask certification certificate. 0 1 China Medical masks belong to the second class of medical devices in China, which are registered and managed by the provincial drug regulatory authorities, and can be inquired through the medical device access number. National Medical Products Administration official website inquiry address: http://app1.nmpa.gov.cn/datasearchcnda/face3/base.jsp?tableId=26&tableName=TABLE26&title=%B9%FA%B2%FA%D2%BD%C1%C6%C6%F7% D0%B5%B2%FA%C6%B7%A3%A8%D7%A2%B2%E1%A3%A9&bcId=152904417281669781044048234789 After entering the page, according to the situation marked above, the commodity information marked on the smallest independent package of the commodity can be input for inquiry. 0 2 United States Medical masks belong to medical devices in the United States and are regulated by the Food and Drug Administration (FDA). Recently, the FDA personally refuted the rumor and stated on its official website that it would not issue certification certificates to any enterprises.
At present, the mask products that have been admitted by the FDA of the United States can be inquired through its official website by inquiring the registration certificate number: https://www.accessdata.fda.gov/s/cdrh/cfdocs/cfPMN/pmn.cfm FDA registration inquiry address: https://www.accessdata.fda.gov/s/cdrh/cfdocs/cfRL/rl.cfm (Mask Product Registration Certificate Enquiry) (FDA Registration Inquiry) According to the latest FDA policy, Chinese standard masks are currently recognized when certain conditions are met. The authorized enterprise link is (list dynamic update): https://www.fda.gov/media/136663/download 0 3 European Union The CE attestation certificate on the market is multifarious, mix with false almost true. An enterprise applying for certification may ask the issuing authority two questions: 1. Is your company a NB Agency? Whether the organization number can be inquired ? 2. Issued Is the CE certificate available on the official website? (Common CE certification fake certificate, pictures from the Internet) The European Union has published a series of institutions authorized by the European Union for unified supervision and certification, which is what we call NB institutions, and granted each institution a unique four-digit code, that is, the announcement number. The application and issuance of CE certificates are issued by the announcement number institutions authorized by the corresponding regulations and directives. The link is as follows https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main Click the position of the corresponding code corresponding to the obtained NB authorization number, and you can query the authorized instructions of the institution after entering. Certificates issued for instructions within the scope of authorization are valid. At present, the EU directives related to masks are: Medical Device Directive 93/42/EEC (MMD) New Regulation (EU) 2017/745 on Medical Devices (MDR) Personal Protective Equipment (PPE) Regulation (EU) 2016/425 04 South Korea Surgical mask belongs to Class II medical equipment products in Korea. MFDS (Ministry of Food and Drug Safety of Korea) carries out pre-market approval for Class II devices. Korea stipulates that importers of such commodities should ensure that imported products meet the requirements of the quality management system and obtain the permission of the MFDS authorized agency. MFDS only issues certificates to domestic companies, and Korean representatives have more responsibilities, so there is no need to worry too much about the authenticity of certificates. 05 Australia Mask products in Australia need to be registered with the TGA of the Australian Government Health Products Authority, which is the supervisory body for therapeutic commodities (including drugs, medical devices, genetic technology and blood products) in Australia. According to Australian Therapeutic Goods (Medical Devices) Regulations 2002, the classification of medical devices in Australia is almost the same as that in the European Union. If the CE certificate issued by the Notified Body of the European Union has been obtained, it can be recognized by TGA and can be used as an important registration information to meet Australian safety regulations. After the TGA is approved, the ATRG registration number will be generated, and the query method is as follows. First, enter the official website. http://www.tga.gov.au/ Select "Australian Register of Therapeutic Goods (ARTG)" in the box to begin the search http://www.tga.gov.au/ The source of the above is from the Ministry of Commerce, the 12360 hotline of Qingdao Customs and the release of the Customs.
How to identify the EU CE certificate? Contributor: Hefei Customs. Source: 12360 Customs Hotline. Comprehensive | Taizhou Market Supervision Bureau, China Quality News Network, Hefei Customs, 12360 Customs Hotline, Customs Junior 2, Qingdao Customs 12360 Hotline, Customs Release, Finishing and Editing | Testing WeChat Platform ID: testbbs Reprint Please Specify Declarations: 1. Part of the graphic information comes from the Internet, and the copyright belongs to the original author. If there is infringement,Full Body Disposable Coverall, inform in time, delete after verification; return to Sohu, see more Responsible Editor:. zjyuan-group.com