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yie 发表于 2020-3-30 16:58 
啊哈!lightbulb moment
有道理!我去问问PM 是不是因为诊所地址的关系。
因为收到CBFCA的邮件如下说,所以联想到产品用途应该是海关扣货的原因。
Face masks and gowns which are non-sterile and designed as safety or protective apparel for use in the home or for recreational or occupational use (for example, nursing) are excluded from regulation by the TGA under the Act."
Face masks or gowns which are presented or claimed to be for therapeutic use, such as being labelled for surgical use, or to reduce or prevent the transmission of disease or micro-organisms such as bacteria or viruses, meet the definition of a medical device and are regulated by the TGA under the Act.
If these masks or gowns are supplied as non-sterile, they are likely to be regulated as low risk, class I medical devices.
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