李国杰（经理）：18202125732电话：021-61062636***物资的FDA证书是哪个机构发放的？WhichorganizationissuedtheFDAcertificateofmedicalmaterials?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”（EstablishmentRegistrationandDeviceListing)，完成的标志是帮助厂家取得了FDA的注册登记号。A:thereisnocertificateforFDAregistrationintheUnitedStates.IftheproductisregisteredinFDA,itwillgettheregistrationnumber.FDAwillgivetheapplicantareply(signedbyFDAChiefExecutive),butthereisnoFDAcertificate.Thecertificateweusuallyseeisissuedbytheintermediaryagency(registrationagent)tothemanufacturertoprovethatithelpsthemanufacturertocompletethe"establishmentregistrationanddevicelisting"requiredbytheUSFDA,andthecompletedmarkistohelpthemanufacturertoobtaintheFDAregistrationnumber.欧盟对口罩的准入要求有哪些？WhataretheEU'saccessrequirementsformasks?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:theEuropeanUniondividesmasksintotwocategoriesaccordingtotheiruse:medicalmasksandpersonalprotectivemasks.ThemedicalmaskshallbeaffixedwithCEmarkinaccordancewithEUmedicaldevicedirective93/42/EEC(MDD)orEUmedicaldeviceregulationeu2017/745(MDR),andthecorrespondingstandardisen14683.Accordingtotheasepticornonasepticstateofthemaskproducts,theconformityasses***entmodeadoptedisalsodifferent.Sterilemedicalmask:itmustbeCEcertifiedbyanauthorizednotifiedbody.Nonsterilemedicalmask:enterprisesonlyneedtomakeCEself-compliancedeclaration,anddonotneedtopassthecertificationofthenotifiedbody.Afterpreparingthecorrespondingdocuments,testreportsandotherdata,thedeclarationofconformitycanbecompletedbyyourself.李国杰（经理）：18202125732电话：021-61062636专注于进出口的物流师在进出口清关的过程中遇到任何问题，都可咨询我，免费为您提供***解答。15年***进口清关团队竭诚为您服务上海|宁波|昆山|深圳|广州|厦门|成都|天津|青岛|北京|大连|***网点服务Intheprocessofimportcustomsclearance,youcanc***ultmeandprovideyouwithprofessionalanswersfreeofcharge.15yearsofprofessionalimportcustomsclearanceteamdedicatedtoserveyouShanghai,Ningbo,Kunshan,Shenzhen,Guangzhou,Xiamen,Chengdu,Tianjin,Qingdao,Beijing,Dalian,nationalnetworkservice)