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The United States Centers For Disease Controland Prevention Announced The Acceptance Of Chinese Standard Masks Such As KN95

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On March 17, the United States centers for disease control and prevention (CDC) released the "optimizing the supply of N95 mask strategy: crisis/alternative strategy", which pointed out that during the covid-19 outbreak, when the supply of N95 masks was insufficient, the masks produced according to the standard in the following table were an appropriate replacement for N95 masks. These include masks produced using Chinese standards GB 2626-2006 and GB/T 18664-2002.

At present, during the epidemic period, entering the US market requires importers to apply to the FDA for emergency mask qualification. N95 masks that meet the following standards can simplify the original US FDA registration process and the testing process of NIOSH, and quickly put into use.

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(The above Chinese form is from the official website of Shenzhen customs, and is provided by Qianhai customs)

Original CDC announcement address:

https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html

Recently, Europe and the United States have urgently relaxed the access requirements (CE certification and FDA certification) for epidemic prevention materials such as masks, Products that require agency certification can be exported before completing the compliance assessment process (that is, before obtaining the CE/FDA mark), but to ensure the certification work will continue to complete.  

The competent authorities of the EU member states can evaluate and centrally purchase quarantine products without CE marking during the epidemic period. The products can only be provided to medical personnel and cannot be sold on the market. If your product is not centrally purchased by the government and is to be sold in the local market, it does not fall into the scope of the above relaxed access conditions.

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