What Compliance Certificates Should Your Suppliers Have?

Sep 24 2021

In China, we have a standard that disposable facial mask is not for medical use. But in European countries and the United States, they don’t have this standard.


So, in some countries, the customs sometimes consider this kind of mask as surgical masks, which means they will require you to provide certifications the same as medical masks. Well, it doesn’t mean that customs will act like the same in every city or country.

surgical masks

If it’s your first time to import and you don’t have any experience in dealing with the customs clearance, and you really want to import masks in large quantities, you’d better find a manufacturer who has certifications for surgical masks.


If the manufacturers want to export surgical masks to the U. S., they should have the certification of ASTM F2100. And to the European Union, the manufacturers should have the CE certification which has the EN 14683 directive.

In most countries, customs will treat respirators more strictly than disposable facial masks. For importing to the European Union, your supplier must provide you with the CE certifications that include the EN149 directive.


If your supplier exports respirator masks to the United States, they must have the NIOSH certification, it can prove the respirators comply with the N95 standard. But if the supplier exports respirator masks to the United States, they also need to register as a manufacturer in FDA.


In addition, you also need to register as an importer in FDA. This is a compulsory registration for all importers who want to import any products that are regulated by FDA. This registration costs about 4,000 USD one year. This is the most legal way to import respirators to the United States in large quantities.


In March, there is a shortage of respirators in America. So as long as the manufacturer gets the FDA registration, Americans temporarily allowed the Chinese standard KN95 respirators imported to the United States. However, they canceled the temporary policy at the end of March.


In April, Chinese KN95 masks can be imported to America as long as these KN95 masks are made by the factories included in the list of Chinese factories they provide, which is allowed by the FDA. Here is the list for your reference.

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