李国杰（经理）：18202125732 电话：021-61062636
***物资的FDA证书是哪个机构发放的？
Which organization issued the FDA certificate of medical materials?
答：美国FDA注册是没有证书的，产品通过在FDA进行注册，将取得注册号码，FDA会给申请人一份回函(有FDA行政长官的签字)，但不存在FDA证书一说。我们通常看到的这个证书是中介代理机构（注册代理）签发给厂家，以证明其帮助该厂家完成了美国FDA要求的“生产设施注册和产品类型注册”（Establishment Registration and Device Listing)，完成的标志是帮助厂家取得了FDA的注册登记号。
A: there is no certificate for FDA registration in the United States. If the product is registered in FDA, it will get the registration number. FDA will give the applicant a reply (signed by FDA Chief Executive), but there is no FDA certificate. The certificate we usually see is issued by the intermediary agency (registration agent) to the manufacturer to prove that it helps the manufacturer to complete the "establishment registration and device listing" required by the US FDA, and the completed mark is to help the manufacturer to obtain the FDA registration number.
欧盟对口罩的准入要求有哪些？
What are the EU's access requirements for masks?
答：欧盟根据用途将口罩分为两类：***口罩和个人防护口罩。***口罩需按照欧盟***器械指令93/42/EEC（MDD）或欧盟***器械条例EU2017/745（MDR）加贴CE标志，对应的标准是EN14683。根据口罩产品无菌或非无菌状态，采取的合格评定模式也不同。无菌***口罩：必须由***公告机构进行CE认证。非无菌***口罩：企业只需进行CE自我符合性声明，不需要通过公告机构认证。在准备好相应文件及测试报告等资料后，即可自行完成符合性声明。
A: the European Union divides masks into two categories according to their use: medical masks and personal protective masks. The medical mask 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 state of the mask products, the conformity asses***ent mode adopted is also different. Sterile medical mask: it must be CE certified by an authorized notified body. Non sterile medical mask: enterprises only need to make CE self-compliance declaration, and do not need to pass the certification of the notified body. After preparing the corresponding documents, test reports and other data, the declaration of conformity can be completed by yourself.
李国杰（经理）：18202125732 电话：021-61062636
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