FDA法规医疗器械问卷 FDA法规医疗器械问卷 Registrar Corp可以为贵司的医疗器械产品提供对应的FDA法规要求（包括自由裁量及紧急使用授权）。您只需将下表填写完整： This field is hidden when viewing the formInternational Office EmailThis field is hidden when viewing the formGCLIDThis field is hidden when viewing the formQuestionnaireMedical DeviceFood SafetyThis field is hidden when viewing the formFlow Type medical_device_general food_safety_wizard This field is hidden when viewing the form debug 提供您的联系方式国家*选择您的国家AfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Sint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos IslandsColombiaComorosCongo, Democratic Republic of theCongo, Republic of theCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicCôte d'IvoireDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEswatini (Swaziland)EthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard and McDonald IslandsHoly SeeHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacauMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalauPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRomaniaRussiaRwandaRéunionSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint MartinSaint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint MaartenSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth GeorgiaSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan Mayen IslandsSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUS Minor Outlying IslandsUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUruguayUzbekistanVanuatuVenezuelaVietnamVirgin Islands, BritishVirgin Islands, U.S.Wallis and FutunaWestern SaharaYemenZambiaZimbabweÅland Islands法定公司名称*联系人姓名*电子邮箱* 电话*手机My devices are intended to be shipped to the following countries for sale:* United States Canada Which FDA requirements would you like assistance with?* Food Safety / HACCP Plan Foreign Supplier Verification Program Food Defense Plan Recall Plan Seafood / Juice Importer Verification Program Supply Chain Program Dietary Supplement MMR I was referred to this Wizard by someone Who referred you?* 下一步 提供贵司的完整地址企业街道地址*城市*州/省/区域邮政编码 前一步 下一步 第步 （共步）This field is hidden when viewing the formDevicesCommon NameDevice ManufacturerProprietary NameIntended UseCompany FunctionLabel (see file below)Website510kPredicate Device This field is hidden when viewing the formDevice Information提供贵司的产品信息提供贵司产品的常用（通用）名称*（例如：胶布或创可贴，手动牙刷，等等）列出产品的品牌名称*（例如：胶布或创可贴，手动牙刷，等等）贵司产品的预期用途是什么？*Device Manufacturer*Identify your company's function related to this device*Please SelectManufacturerImporterDistributor 下一步 This field is hidden when viewing the formLabel Information您是否有产品的标签？* 是 否 上传贵司的标签 Drop files here or Select files Max. file size: 50 MB. 上传贵司的标签 Drop files here or Select files Max. file size: 50 MB. 上传贵司的标签 Drop files here or Select files Max. file size: 50 MB. 上传贵司的标签 Drop files here or Select files Max. file size: 50 MB. 上传贵司的标签 Drop files here or Select files Max. file size: 50 MB. 前一步 下一步 File UploadsUpload any relevant documentation on your device.产品资料上传产品图册，说明书/资料单，或使用手册 Drop files here or Select files Max. file size: 50 MB. 产品资料上传产品图册，说明书/资料单，或使用手册 Drop files here or Select files Max. file size: 50 MB. 产品资料上传产品图册，说明书/资料单，或使用手册 Drop files here or Select files Max. file size: 50 MB. 产品资料上传产品图册，说明书/资料单，或使用手册 Drop files here or Select files Max. file size: 50 MB. 产品资料上传产品图册，说明书/资料单，或使用手册 Drop files here or Select files Max. file size: 50 MB. 提供该产品的任何宣传链接例如，电子网页清单或者产品页面 前一步 下一步 This field is hidden when viewing the form510(k) Information贵司是否曾向FDA递交过510(k)申请?* 是 否 510(k)号码*若您认为贵司的产品需要510(k)，请提供其等价器械等价器械是指某个医疗器械在以下这些方面与贵司的产品实质等同：预期用途、设计、使用或输送的能量、材料、性能、安全性、有效性、标签、生物相容性、标准，以及其它特性 及其510(k)号码。否则，下方请放空白。等价器械等价器械510(k)号码 前一步 下一步 前一步 添加另外一个产品 查阅 前一步 下一步 Provide information for the chief technical officer for this device. (This must be an employee or consultant with sufficient expertise to provide complete and accurate technical information concerning the device)This field is hidden when viewing the formPhone Previous Next Add Another Device Previous Review Which of the following best describes your location?* I manufacture / process food products I import food products into the United States I manufacture and import food products for consumption in the United States Previous Next Which of the following best describes your global annual sales and U.S. market value of the food you manufacture, process, pack, hold or import?*(averaged over the previous three years, including affiliates and subsidiaries) Less than $1 million $1 million - $2.5 million $2.5 - $10 million More than $10 million Do you have a Preventive Controls Qualified Individual or a HACCP qualified individual?* Yes No Do you have a qualified individual to perform FSVP responsibilities?* Yes No Select all activities conducted at this location*FarmingHolding/StorageLabelingManufacturing/ProcessingPackingOtherSpecify Other* Previous Next Step of ProductsProduct NameIntended ConsumerType of FoodVarietiesAll Intended UsesStoragePackagingOwner of Product at EntryProduct ManufacturerLikely Requirements Basic Product InformationThis field is hidden when viewing the formEstimated RequirementsProvide information about your food or beverage product. (You may add additional products later in the form.)Provide the name of the product*Indicate the type of food*100% JuiceBakeryBeverageChocolate and CandyDairyDietary SupplementsDressing and CondimentsEggFood AdditivesFruits and VegetablesGrainsHerbs and SpicesInfant FormulaNuts and SeedsOilsProduceSeafoodSnack FoodsSoupsSweetenersOtherSpecify Other*List all flavors / varieties of this product that you are handling for consumption in the U.S.*(separate varieties by comma or line) Specify the Manufacturer of this Product*Who owns the product at time of entry? My company Another Company Fulfilled by Amazon Identify the owner of the product at entry Next This field is hidden when viewing the formProduct DetailsIndicate the intended consumer of the product* Humans Animals Select all intended uses of the food*Bulk SaleFinished ProductRaw material/Ingredient for further processingReady-to-eatRetail SaleOtherSpecify Other* Previous Next This field is hidden when viewing the formStorage/PackagingSelect how the foods will be stored and distributed* Frozen Refrigerated Shelf-stable Type of packaging for finished product*BagCanDrumGlassHermetically-sealedVacuum PackedModified AtmospherePlasticPouchMetalOtherSpecify Other* Previous Next File UploadsUpload the food safety documentation specific to this product. (Please upload files in English if possible)Upload the food safety documentation specific to this product from your suppliers. (Please upload files in English if possible)Upload Food Safety FilesUpload product labels, descriptions/specifications, flow diagrams, hazard analysis, and Food Safety/HACCP plans. Drop files here or Select files Max. file size: 50 MB. Upload Food Safety FilesUpload product labels, descriptions/specifications, flow diagrams, hazard analysis, and Food Safety/HACCP plans. Drop files here or Select files Max. file size: 50 MB. Upload Food Safety FilesUpload product labels, descriptions/specifications, flow diagrams, hazard analysis, and Food Safety/HACCP plans. Drop files here or Select files Max. file size: 50 MB. Upload Food Safety FilesUpload product labels, descriptions/specifications, flow diagrams, hazard analysis, and Food Safety/HACCP plans. Drop files here or Select files Max. file size: 50 MB. Upload Food Safety FilesUpload product labels, descriptions/specifications, flow diagrams, hazard analysis, and Food Safety/HACCP plans. Drop files here or Select files Max. file size: 50 MB. Previous Add Another Food Product Review 查阅贵司的产品并提交 Review your products and submit. To make changes to a product or upload new documents, simply click the product's "edit" button. CAPTCHA 提交 Δ
