What Are The Requirements Of Export Mask Countries?

- Apr 24, 2020-

Domestic export (company)


For sale


Only those who have a medical device operation license within the scope of business, and the right to import and export, can be exported.


For gift or substitute purchase


As a gift or purchased on behalf of an affiliate company (brother company, parent or subsidiary company), the relevant qualification certificates of the purchased manufacturer or the company ’s domestic manufacturer must be provided, and three certificates (business license, product medical (Device certification, manufacturer inspection report).


Foreign imports


Korea:


Necessary information (qualification)


Bills of lading, packing slips, invoices, business licenses of Korean importers, Korean consignees need to go to Korea Pharmaceutical Traders Association. Import qualifications are filed in advance (nothing wrong) 


The enterprise's own use is also a gift, and it can be imported by itself without the relevant qualifications.


Mask requirements


Masks also need to have a detailed mark of origin. If it is made in China, it must have a label: Made in China, manufacturer information, shelf life, preparation of ingredient content description, manufacturing process, these documents are not over yet, need After the goods arrive in South Korea, they will be fine-tested and sent samples to the laboratory. After passing the test, they can enter the Korean market for sale and circulation.


European countries:


Necessary information (qualification)


Bill of lading, packing list, invoice


Mask requirements


In the European Union, masks are "health-threatening substances and mixtures". From 2019, the new EU regulations PPE Regulation (EU) 2016/425 will be enforced. All masks exported to the EU must obtain CE certification under the requirements of the new regulations.


CE certification is a mandatory product safety certification system implemented by the European Union, the purpose is to protect the safety of life and property of the people of the European Union countries.

United States: Necessary information (qualification) Bill of lading, packing list, invoice For masks imported from the United States, if they need to be sold, they must obtain FDA certification before they can be sold in the US domestic market. For self-use and gift masks, it is best to ask the United States whether they need FDA certification or to purchase masks that were originally certified by FDA for export.


Mask requirements


According to HHS (United States Department of Health and Human Services) regulations, NIOSH (National Institute of Occupational Safety and Health) classified its certified anti-particulate masks into 9 categories. The specific certification is operated by the NPPTL laboratory under NIOSH.


In the United States, according to the minimum filtration efficiency of the filter material, the masks can be divided into three levels-N, R, P.


N-type masks can only filter non-oily particulate matter, such as: dust, acid mist, paint mist, microorganisms, etc. Most suspended particles in air pollution are also non-oily.


The R mask is only suitable for filtering oily particulates and non-oily particulates, but when used for oily particulates, the limited use time should not exceed 8 hours.


P-type masks can filter both non-oily particulates and oily particulates. Oily particulate matter such as: oil fume, oil mist, etc.


According to the difference in filtration efficiency, there is also a difference of 90,95,100, which refers to the minimum filtration efficiency of 90%, 95%, 99.97% under the test conditions specified in the standard.


N95 is not a specific product name. As long as it conforms to the N95 standard and has passed the NIOSH review, the product can be called "N95 mask".