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如何快速将口罩卖到美国?
中国是全球口罩、防护服的最大生产国和出口国。尤其是面对疫情的蔓延,通过复工复产、扩能增产,我国防疫物资生产能力快速提升。 2020年1-2月,就有超过3000家企业新增“口罩、防护服、消毒液、测温仪”等业务。 截止3月6日,全国口罩日产量已超过1亿只,基本上可以满足国内的需求了。 但是当前全球新冠肺炎疫情风险明显升级,口罩防护服等防疫物资出现告急,以口罩为例,目前全球
2020/03/11


中国是全球口罩、防护服的最大生产国和出口国。尤其是面对疫情的蔓延,通过复工复产、扩能增产,我国防疫物资生产能力快速提升。


 

2020年1-2月,就有超过3000家企业新增“口罩、防护服、消毒液、测温仪”等业务。


 

截止3月6日,全国口罩日产量已超过1亿只,基本上可以满足国内的需求了。


 

但是当前全球新冠肺炎疫情风险明显升级,口罩防护服等防疫物资出现告急,以口罩为例,目前全球各地面临脱销状况,疫情严重的多个国家出现了防疫物资短缺抢购潮


 

不少企业家,外贸公司已经嗅到商机,提前转型开始生产口罩,防护服等防疫物资,准备出口。不过由于以前的主营产品并不是口罩,很多企业对国外的法规并不熟悉



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美国为例,目前很多企业向我们提得最多的问题大概有如下四个问题:


 

1. 口罩出口美国需要做什么认证?


 

2. FDA是认证还是注册


 

3. 医用口罩和普通口罩都是做FDA吗?有什么不同吗?费用如何?周期如何?


 

4. 通过FDA难吗?需要企业有什么资质吗?

 

 

我们在这里先梳理一下口罩出口美国的相关问题,后续我们将对其他国家,比如:韩国,日本,伊朗等国家和地区的出口流程和相关法规进行梳理。


 

除了口罩,我们还将对防护服,护目镜,橡胶手套,棉签/棉棒/棉球,体温计,消毒液,洗手液等相关物资的法规进行详细梳理,希望可以协助到中国的企业。

 


 

一、口罩出口美国需要做什么认证?

 

答:FDA注册认证

 

那么什么是FDA?

 

FDA是食品药品监督管理局(Food and Drug Administration)的简称。FDA有时也代表美国食品药品监督管理局。FDA由美国国会即联邦政府授权,是专门从事食品与药品管理的最高执法机关,也是一个由医生、律师、微生物学家、化学家和统计学家等专业人士组成的致力于保护、促进和提高国民健康的政府卫生管制的监控机构。其它许多国家都通过寻求和接收 FDA 的帮助来促进并监控其本国产品的安全。

 


 

二、 FDA是认证还是注册


答:严格意义上来讲,FDA注册认证并不算是认证,它是一种追溯机制


美国FDA 是美国政府在健康与人类服务部 (DHHS) 下属的公共卫生部(PHS) 中设立的执行机构之一。FDA主要分测试注册两个内容,医疗器械化妆品食品药品类产品需要进行FDA注册,FDA注册可以直接在FDA官方网站上进行申请。


从这个角度上来说,医用口罩是需要进行注册的;普通口罩根据不同的防护等级进行普通的检测。

 


 

三、医用口罩和普通口罩都是做FDA吗?有什么不同吗?费用如何?周期如何?


答:医用口罩和普通防护口罩的要求是不同的。


 

医用口罩

 

医用口罩在美国属于II类医疗器械,是有严格的审查和认证机制,大概流程为:

 

①产品测试(性能测试、生物学测试);

②准备510K文件,提交FDA评审;

③FDA发510K批准信;

④完成工厂注册和机器列名;

⑤产品出口。

 

周期很长,相当麻烦!总费用超过:10万元RMB


具体请参考文章《烦人的510K!我只是想在亚马逊上面做点小生意而已!》

 


普通防护口罩

 

普通防护口罩可以按照I类医疗器械来进行FDA注册,大概流程是:

 

①填写申请表格,信息确认;

②获取PIN码,交付年费;

③下发注册号;

④产品出口。

 

周期预计7-10个工作日


费用组成是:注册服务费+年费


年费是固定5236美金(以官方实际报价为准,每年会有小幅波动),注册服务费请联系我司工程师给您报价!


 先 生:15818318918                联系QQ:2851379150                 微     信: jiangyao15818318918


 

美国医用N95及以上9种口罩认证要求:


按照NIOSH认证标准,企业需寄送样品至NIOSH实验室实施测试,同时提交技术性资料(包括质量体系部分资料)至NIOSH文审,文审和测试都通过后,NIOSH核发批文。

 

这种类型的口罩操作也比较复杂,如有需要也请详细咨询我们的工程师。


 

目前要想快速将口罩出口到美国,按照普通防护口罩进行I类FDA注册,是最快的!

 


 

四、通过FDA难吗?需要企业有什么资质吗?

 

答:I类医疗器械FDA注册是三个里面最简单的,主要是需要提供详细的资料,周期也比较快,不需要企业有特别的资质,营业范围有覆盖就行了。

 

有一点要注意就是申请FDA注册需要有美国代理人(或者说是责任人),这个人必须是美国本地,有合法身份的居民,需要提供电话,FDA随时可以与其联系的上,一旦产品出现问题,FDA将通过美国代理人对生产企业进行追溯!(这个人可以是您在美国的经销商,如果您没有代理人,我们有长期合作的代理人,您只需要安心出货!)

 

其他两类对企业本身的有要求的,II类医疗器械的FDA注册是需要企业有CFR820体系审核和510K文件。

 

 

为什么选择我们?

 

1. 预评估

有专业的工程师,可以根据产品的实际情况免费确认所属类别,提前评估确保一次注册成功

 

2. 省事儿

提产品和名片,我们帮您整理申请表资料;并且免费提供申请资料中英文翻译;我们有各种510K文件的模板,可以提供给您参考!

 

3. 服务全

我们可以提供美国代理人服务,您甚至可以在美国没有代理人!

 

4. 可查询

证书下来后,您可以随时登录FDA官方网站,进行证书查询真实可靠

 

5. 性价比

同样的价格比服务;同样的服务比价格

  

更多细节,请联系我们的客户经理,即使您不跟我们合作,我们依然乐意给予您一些专业的参考建议。

 

 先 生:15818318918                

联系QQ:2851379150                 

微     信: jiangyao15818318918



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