醫療類口罩出口，需要注意目的地進口國海關的要求，國外有可能需要提供產品的醫療器械注冊登記證、檢測報告、產品認證如CE認證（歐洲）、FDA認證（美國）、收貨人需要進行特殊備案等等。建議企業出口前務必聯系當地接收方落實相關政策，以免口罩物資被扣或者被退回。

以下國外進口醫用口罩政策，僅供參考：

韓國，收貨人需要到韓國藥監局提前備案進口資質；

日本，要求國外的制造商必須向PMDA注冊制造商信息。

歐盟，出口歐盟的口罩必須獲得CE認證證書；

美國，必須拿到FDA認證才可在美國市場進行銷售

For the export of medical masks, it is necessary to pay attention to the requirements of the customs of the destination importing country. Foreign countries may need to provide the registration certificate, test report, product certification of the products, such as CE certification (Europe), FDA certification (United States), special record of the consignee, etc. It is recommended that the enterprise contact the local receiver to implement relevant policies before export, so as to avoid the bucking or return of mask materials.

The following policies for imported medical masks are for reference only:

In South Korea, the consignee needs to file the import qualification with the Korean drug administration in advance;

Japan requires foreign manufacturers to register manufacturer inbation with PMDA.

EU, masks exported to EU must obtain CE certification;

In the United States, FDA certification is required to sell in the U.S. market

李國杰（經理）：18202125732  

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