出口日本的PMDA注冊醫療器械公司希望把產品投放到日本市場必須要滿足日本的Pharmaceutical and Medical Device Act (PMD Act)，在PMD Act的要求下，TOROKU注冊系統要求國外的制造商必須向PMDA注冊制造商信息。包裝上印有ウィルスカット99%的字?樣?都是超過國內過濾效率95%（N95口罩）標準的醫用口罩!

1. 醫用防護口罩：符合中國GB 強制性標準，過濾效率≥95%（使用非油性顆粒物測試）。

2. N95口罩：美國NIOSH認證，非油性顆粒物過濾效率≥95%。

3. KN95口罩：符合中國GB 2626 強制性標準，非油性顆粒物過濾效率≥95%歐盟

4、必要資料（資質）

提單，箱單

5、在歐盟，口罩屬于PPE個人防護用品，“危及健康的物質和混合物”。2019年起，歐盟新法規PPE Regulation (EU) 2016/425強制執行，所有出口歐盟的口罩必須在新法規的要求下獲得CE認證證書。CE認證是歐盟實行的強制性產品安全認證制度，目的是為了保障歐盟國家人民的生命財產安全。

美國目前并沒有官方禁止口罩出口的消息。建議中國賣家及時關注國內外防疫物資出口資質認證和監管要求，避免造成產品被扣押和退回的風險。屬于醫療器械類的口罩，不同國家的資質和要求都不相同，這點賣家們一定要注意。

1. Medical protective mask: comply with Chinese GB compulsory standard, with filtration efficiency ≥ 95% (test with non oily particles).

2. N95 respirator: NIOSH certified, the filtration efficiency of non oil particles ≥ 95%.

3. Kn95 respirator: it meets the mandatory standard of China GB 2626, and the filtration efficiency of non oil particles ≥ 95% of EU

4. Necessary inbation (qualification)

Bill of lading, packing list, invoice

5. In the European Union, masks are PPE personal protective equipment, "substances and mixtures dangerous to health". From 2019, the new EU regulation PPE regulation (EU) 2016 / 425 is enforced. All masks exported to the EU must obtain CE certification under the requirements of the new regulation. CE certification is a compulsory product safety certification system implemented by EU, which aims to protect the life and property safety of EU people.

There is no official ban on the export of masks in the United States. It is suggested that Chinese sellers should pay attention to the export qualification certification and regulatory requirements of domestic and foreign anti epidemic materials in time to avoid the risk of product seizure and return. The qualification and requirements of respirators belonging to medical devices are different in different countries. The sellers must pay attention to this.

李國杰（經理） ：18202125732 

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