中國出口

一般貿易：需要經營范圍內有醫療器械經營許可證，進出口權的才能出口。

贈送或代為采購：作為贈送的，或者代關聯公司（兄弟，母子公司）采購的，要提供采購的廠家或公司的國內生產廠家的相關資質證明文件。

援助物資（慈善捐贈）：適用于國際組織無償援助和贈送的物資，需要取得相關批文后準予按照援助物資出口，無經營許可和銷售證明要求。

General trade: medical equipment business license is required within the business scope, and only those with import and export rights can be exported.

Gift or purchase on behalf: for gift or purchase on behalf of related companies (brothers, parent and subsidiary companies), relevant qualification certificates of manufacturers or domestic manufacturers of the company shall be provided.

Aid materials (charitable donation): it is applicable to the materials provided and donated by the state or international organizations free of charge. It is required to obtain the relevant approval documents and then it is allowed to export according to the aid materials, without the requirements of business license and sales certificate.

日本

必要資料（資質）：提單，箱單，fapiao。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。

口罩要求：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。

PFE：0.1um微粒子顆粒過濾效率

BFE：細?菌?過濾率

?VFE：病毒過?濾率

ウィルスカット：病毒攔截

醫用防護口罩：符合中國GB19083-2010強制性標準，過濾效率≥95%（使用非油性顆粒物測試）。

N95口罩：美國NIOSH認證，非油性顆粒物過濾效率≥95%。

KN95口罩：符合中國GB2626強制性標準，非油性顆粒物過濾效率≥95%。

Necessary inbation (qualification): Bill of lading, packing list, fapiao. PMDA registered medical device companies exporting to Japan must meet the requirements of pharmaceutical and medical device act (PMD act) of Japan in order to put their products into the Japanese market. Under the requirements of PMD act, toroku registration system requires foreign manufacturers to register inbation with PMDA manufacturers.

Mask requirements: 99% of the words and samples printed on the package are medical masks that exceed 95% of the domestic filtration efficiency (N95 mask).

PFE: 0.1um particle filtration efficiency

BFE: fine bacteria filtration rate

VFe: viral filtration rate

ウ ィ ル ス カ ッ: virus interception

Medical protective mask: in accordance with the compulsory standard of gb19083-2010, the filtering efficiency is ≥ 95% (non oily particles are used for testing).

N95 mask: certified by NIOSH, the filtration efficiency of non oil particles is ≥ 95%.

Kn95 respirator: it meets the mandatory standard of gb2626 in China, and the filtration efficiency of non oil particles is ≥ 95%.

李國杰（經理）：18202125732  

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