近期,在短短不到两周的时间内美国对中国产的口罩政策已经完全翻转,从接受突然变成拒绝。
不久前,3月17日美国CDC刚公布了一个“优化N95呼吸器供应的策略:危机/替代策略”,批准了其它国家与N95同级别的口罩可以在美国替代使用,名单中包含巴西,韩国,日本,澳大利亚,欧洲,墨西哥和中国(含国内的四个口罩型号:KN100, KP100, KN95, KP95),共七个国家和地区。
但是在3月28日,也就是上周六,美国食品药品管理局FDA又推出了一个新的“紧急使用管理”(Emergency-Use-Administration, 简称EUA),声明可以满足指定性能标准的可接受的呼吸器产品只有六个国家和地区,其中独独少了中国一家!
瞧瞧,老美还是很傲娇呵,但始终感觉就是小孩子的赌气和较劲。
这就意味着别人家的口罩只要满足自己国家或地区的N95级别的标准就可以卖到美国去了,但中国的不行,中国的口罩一定要达到NOISH-N95的标准和认证才能在美国使用,此处只剩一个字:服。
但是,据说新冠专治各种不服....
做外贸的小伙伴们,建议大家回复美国客人时要讲清来龙去脉,一是让客人知道他们的政府管理部门究竟做了什么,二是也显得咱们够专业不是。
Dear xxx,
Thank you very much for your inquiry and your trust on us. But I am afraid that we cannot supply the KN95 masks to you and to US.
Not long before, CDC announces:"Use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators". At that time, we were very glad that KN95 and other FFRs meeting Chinese Standards are admitted to be used in US.
Pls kindly find the document at https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html
But on March 28, surprisingly FDA released a new EUA which denied and deleted only Chinese FFRs from the former list.
Pls kindly find the latest EUA at https://www.fda.gov/media/136403/download
So I am afraid we cannot export the masks any more to US. We are too upset that we cannot help you more in this emergency case. But, maybe we could talk about other products?
God bless you and America!
Best regards,
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