Recently, the European Safety Federation (ESF), the EU's food and drug safety agency, issued an official warning: Regarding the "certificates" used as the basis for the CE marking of PPE (including FFP2/FFP3 masks and goggles), these "certifications" are forged or issued without authorization. These "certificates" have no legal value and cannot be used as conclusions for conformity assessment! In this EU ESF official warning, ESF pointed out that these so-called "certificates" used as the basis for the CE marking of PPE (including FFP2/FFP3 masks and goggles) have the following serious problems: 1. These so-called "certifications" have no legal value! 2. These "certifications" cannot be used as valid proof of product qualification 3. It is not clear whether these documents are actually issued by some (unauthorized) organization themselves, or whether they are completely forged! At the same time, the European Safety Federation (ESF) pointed out in the announcement that for any product imported into the EU from outside the EU, a Declaration of Conformity (DoC) must be provided and checked. In addition, ESF also named 21 non-compliant companies, including 9 from Europe and 10 from China . The nine European certification bodies named are: ICR Polska, CELAB, ISET, ECM, NPS, Amtre Veritas , STS Inspection and Certification, VIC Testing and Certification, and BSI. The 10 Chinese certification bodies named are: CIC (Shenzhen CIC Testing Technology) Huaxun (Shenzhen HX Detect Certification) ENC (East Notice Certification Service) HTT (Shenzhen HTT Technology) ITC (Shenzhen ITC Product Testing) BTK (Guangzhou Bestek Testing Services) Micez (Shanghai MICEZ Testing & Technical) Huawei (Shenzhen Huawei Testing Certification) LTT (Shengzhen LTT Testing Technology) AST.LAB (Aerospace Testing Technology (Shenzhen) Medical masks are classified as Class II medical devices in China and are registered and managed by provincial-level drug regulatory authorities. They can be queried through the medical device access number query. First open the official website http://www.nmpa.gov.cn/ Select data query under the "Government Affairs Disclosure" column http://www.nmpa.gov.cn/ After entering, select the medical device column as needed. http://www.nmpa.gov.cn/ After entering this page, you can search by entering the product information indicated on the smallest independent packaging of the product according to the above instructions. The mask products that have been approved by the US FDA can be queried through their official website to check the registration certificate number. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm According to the latest FDA policy, masks that meet Chinese standards are currently recognized if certain conditions are met. The authorized company link is https://www.fda.gov/media/136663/download Is your company a NB institution? Can the institution number be checked? Can the issued CE certificate be checked on the official website? (Common fake CE certification certificates, pictures from the Internet) Links below https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main Corresponding to the NB authorization number obtained, click on the corresponding code location, and then you can query the instructions authorized by the agency. The certification certificate issued for instructions within the scope of authorization is valid. At present, the EU and mask-related directives are: Medical Device Directive 93/42/EEC (MMD), New Medical Device Regulation (EU) 2017/745 (MDR), Personal Protective Equipment (PPE) Regulation (EU) 2016/425. First, go to the official website http://www.tga.gov.au/ Select 'Australian Register of Therapeutic Goods (ARTG)' in the box to start your search http://www.tga.gov.au/ Source: Cross-border Live |
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