The epidemic of new coronary pneumonia continues to spread, and the global demand for masks, isolation gowns and other protective products has surged. As a major mask manufacturing country, China's mask production capacity and export situation have attracted much market attention.
According to relevant regulations, masks, disposable isolation gowns and other anti-epidemic materials exported by China need to have certain qualifications before they can be sold in the United States, the European Union, Japan and South Korea and other countries and regions after passing the relevant certification. Among them, the most concerned are the CE certification of the European Union and the FDA certification of the United States. The US FDA certification is relatively strict overall. For example, the general protective mask only needs to be certified according to the US FDA medical class I, it usually needs to go through the process of filling in the form and applying, obtaining the PIN code, and paying the annual fee until the registration number is issued. However, medical surgical masks need to be certified in accordance with FDA medical class II, adding multiple links such as product testing, 510k document review, etc. As for the certification of the medical N95 mask and above masks that are widely concerned in the market, the NIOSH certification standard needs to be implemented. The enterprise needs to send samples to the NIOSH laboratory for testing, and submit technical information (including some data of quality system) to the NIOSH. NIOSH will issue the approval only after the document review and test are passed.
As a major mask-producing country, China has recently provided masks and other protective materials to other countries through donations, exports, etc. to provide the necessary guarantee for their prevention and control of epidemics.