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["附件2"]
["取得国外标准认证或注册的医疗物资生产企业清单\n\nList of manufacturers of medical products that have obtained certification or registration in accordance with foreign standards / norms"]
["企业名称\n(中英文) \n\nCompany Name\n(CN&EN)","经营企业代码\n\nBusiness Company Code","产品名称\n(中英文)\n（含规格、型号）\n\nProduct Name\n(CN&EN)\n(including Specifications, Model )","产品分类\n（按选项填写） \n\nProduct Classification\n(Selection from the Drop-Down Menu)","进口国（地区）  \n\nImport Country (Region)","已获得国外认证和注册情况\n（附证书) \n\nInformation on valid foreign certifications / registration / approval (with attached proof) ",null,null,"资质文件\n（请标明序号）  \n\nVerification Documents\n(with serial numbers)","企业联系人\n\nResponsible person at the company","联系方式\n\nContact"]
[{"$nulls":5},"CE\n\n（按选项填写）  \n\n(Selection from the Drop-Down Menu; \n1: CE certificate + DOC\n2: DoC + proof of product notification)","FDA\n\n（按选项填写） \n\n(Selection from the Drop-Down Menu)","其他\n（请列明）\n\nOthers\n(please specify)"]
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["填写说明 Instructions for completing the form"]
["1.       填报范围仅限于五大类医用物资，即新冠病毒检测试剂、呼吸机、医用防护服、医用口罩、红外体温计；\n          The form is only applicable for five categories of medical devices, namely COVID-19 test kits, ventilators, medical protective clothing, medical masks, and \n           infrared temperature measurement devices."]
["2.       请按产品填写，每个产品一行；\n           Fill in according to product; one line per product"]
["3.       “企业名称”栏请务必填写中英文名称，同一家企业的多个产品请依次填写，企业名称列不合并单元格；\n            In the colum \"company name\", Chinese and English names must be included. Several products of the same manufacturer are to be listed individually; \n            no merged cells in the column company name.\n\n"]
["4.       “产品名称”请列明中英文具体名称、规格、型号等，并注明无菌或非无菌；\n            In the field \"product name\" the Chinese and English name, specification, model, etc. have to be indicated. It must be specified whether the product is sterile \n            or non-sterile"]
["5.       同一产品出口不同国家（地区），请在“进口国（地区）”单元格中合并填写，无须每个国家一行；\n           If the products are exported to multiple countries (regions), please write the names of the countries/regions in one cell in the column \"Importing country (region)\", \n           without using a new row for each country/region."]
["6.       请务必提交本表中已填写的国外认证和注册文件，在“资质文件”列的同一个单元格中按序号列明；\n           The foreign certification and registration documents named in the form are to be submitted. The relevant documents are to be listed according to serial numbers in the \n           same cell of the column Verification Documents."]
["7.      本表格中已填写的“资质文件”，请统一放置到一个文件夹中，文件夹以企业中文名称命名，\n          相关资质文件命名方式为：序号+企业中文名称缩写+产品名称+证书或检测报告名称，序号请务必与表格中“资质文件”列的序号相同；\n \n          The documents named in this form are to be compiled in a folder. The folder is to be named after the Chinese company name.\n          Relevant verification documents are to be named as follows: serial number + abbreviation of the Chinese company name + product name + \n       title of the certificat or test report\n          Please be advised, that the serial numbers must match the serial numbers written in the column \"Verification Documents\" in the form.\n"]
[" "]

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[null,"注明：主要应急物资认证及审核资料，请大家对照这个按照产品类别，提交完整资料，便于加快审核。建议一类产品一个文件夹，每个文件夹里面按照注册国别对提供的材料进行编号\n\nNote: Please submit complete documents regarding certification and inspection of the urgently needed equipment according to the following product classifications, in order to speed up the evaluation process. It is recommended to create a folder for each product category and in each folder to mark the documents for the correspondings countries with serial numbers. "]
[null,null,"欧盟认证所需提交的审核资料\n\nrequired documentation regarding certification / approval in the EU","美国认证所需提交的文件资料\n\nrequired documentation regarding certification / approval in the USA","其他国家注册认证所需提交资料\n\nrequired documentation regarding certification / approval in other countries"]
[null,"医用口罩\n\nMedical masks","非灭菌提交资料：\n1）企业按照医疗器械指令93/42/EEC或医疗器械新法规MDR出具的符合性声明DoC\n2）欧盟授权代表在对应欧盟成员国的主管当局进行登记注册的凭证\n\nNon-sterile masks\n1)   Declaration of Conformity (DoC)  issued by companies according to MDD\n      (Medical Devices Directive) 93/42/EEC or MDR (Medical Devices Regulation)   \n2)  Proof of registration/notification by the European Authorised Representative\n      within the corresponding authorities of the relevant EU Member State","企业英文名、注册号、510K号\n\nCompany name in English,\nRegistration number, 510(k)","请提供注册证书，及对方国家官方网站关于注册证书的链接\n\nRegistration certificates and links to official websites of the corresponding countries regarding registration certifications"]
[null,null,"灭菌提交资料：\n由具有资质的公告机构按照医疗器械指令93/42/EEC或医疗器械新法规MDR签发的CE证书\n\nSterile masks: \nCE certificates issued by qualified Notified Bodies according to MDD (Medical Devices Directive) 93/42/EEC or MDR (Medical Devices Regulation)"]
[null,"呼吸防护口罩\n\nRespirator Protective Mask","相应资质的公告机构签发的CE证书\n\nCE certificates issued by appropriately qualified Notified Bodies (NBs)","NIOSH，EUA"]
[null,"MD（非灭菌Class I）：手术衣、隔离衣等\n\nMD (non-sterile class I): surgical gown, isolation gown, etc.","1）符合性声明DoC \n2）欧盟授权代表在对应欧盟成员国的主管当局进行登记注册的凭证\n\n1)  Declaration of conformity DoC\n2)  Proof of registration of the European Authorised Representative with the \n     corresponding authorities of the relevant EU Member State","1）企业英文名称\n2）注册号\n3）产品510k号（灭菌级别需要提供）\n  \n1) Company name in English\n2) Registration Number\n3) 510(k) (required for sterile class)"]
[null,"MD（灭菌Class I*）：手术衣、隔离衣等\n\nMD (Sterile Class I *): surgical gown, isolation gown, etc.\n","由具有资质的公告机构签发的CE证书\n\nCE certificates issued by appropriately qualified Notified Bodies"]
[null,"PPE（Category III）","相应资质的公告机构签发的CE证书\n\nCE certificates issued by appropriately qualified Notified Bodies (NBs)"]
[null,"新冠病毒检测试剂盒\n\nCOVID-19 Testkits\n","1）企业按符合性声明DoC\n2）欧盟授权代表在对应欧盟成员国的主管当局进行登记注册的凭证\n\n1)  Company's Declaration of conformity (DoC) \n2)  Proof of registration/notification by the European Authorised Representative with the   \n     corresponding authorities of the relevant EU Member State","提供企业英文名和注册号\n\nCompany name in English,\nRegistration number, 510(k)"]
[null,"呼吸机\n\nVentilators","由具有资质的公告机构按照医疗器械指令93/42/EEC或医疗器械新法规MDR签发的CE证书\n\nCE certificates issued by appropriately qualified Notified Bodies according to MDD (Medical Devices Directive) 93/42/EEC or MDR (Medical Devices Regulation)","企业英文名、注册号、510K号\n\nCompany name in English,\nRegistration number, 510(k)"]
[null,"红外线体温计\n\nInfrared Temperature Measurement Devices.","由具有资质的公告机构按照医疗器械指令93/42/EEC或医疗器械新法规MDR签发的CE证书\n\nCE certificates issued by appropriately qualified Notified Bodies according to MDD (Medical Devices Directive) 93/42/EEC or MDR (Medical Devices Regulation)","企业英文名、注册号、510K号\n\nCompany name in English,\nRegistration number, 510(k)"]