Mask export: The EU can obtain CE.FDA certification in as fast as 3 days, and foreign trade companies are ready

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👉 Certified mask products

The outbreak of new pneumonia has continued to spread, and the demand for protective masks and other protective equipment has surged overseas. As a major mask manufacturing country, China’s mask production capacity and export situation have attracted much market attention.

A reporter from the Finance Association learned that the business of export certification services for masks has been very hot recently, and some consultants said that mobile phones have been “beaten up.” In order not to let customers miss the “Quote”, some organizations have launched the “Express Service” that is certified within the fastest 3 working days.

However, due to a significant increase in the number of certification applications recently, several EU CE certification agencies have stopped issuing certificates. In contrast, some listed companies engaged in the production of masks said that they still give priority to ensuring domestic prevention and control needs, and they can only consider exporting after the end of the domestic epidemic.

Get CE / FDA certification on the 3rd

Ms. Su is a consultant of a third-party testing and certification service organization in Shenzhen. Her company mainly provides qualification certification services for some domestic manufacturers in the United States, Europe, Japan and South Korea and other countries and regions. In an interview with a reporter from the Financial Associated Press, Ms. Su revealed that she recently asked her to consult with manufacturers of mask export certifications. “There are many.”

While providing certification services, Ms. Su also helped some foreign trade companies to find suppliers. She said that the enthusiasm of foreign trade companies has also soared recently, and they are contacting mask manufacturers with similar service agencies.

According to the relevant regulations, the masks exported by China need to have certain qualifications, and only after passing the relevant certifications can they be sold in the United States, the European Union, Japan and South Korea and other countries and regions. Among them, the most concerned are the CE certification of the European Union and the FDA certification of the United States.



CE certification is regarded as a passport for manufacturers to open and enter the European market. According to the reporter, if the masks are to be exported to EU countries, they need to obtain the CE certificate issued by the NB agency (notified agency authorized by the PPE regulations). The current EU implementation standards for personal protective masks and medical masks are EN149 and EN14683, respectively. Because of the different implementation standards, the masks of different protection levels need to provide different materials and execute different procedures. But overall, the process of applying for personal protective masks is relatively simple, time-consuming and relatively low-cost.

The US FDA certification is relatively strict overall. For example, general protective masks only need to be certified according to the US FDA medical class I, and usually need to go through the process of completing the application form, obtaining the PIN code, paying the annual fee until the registration number is issued, but medical surgical masks need to be certified according to the US FDA medical class II. , Increase product testing, 510K document review and other links. As for the certification of the medical N95 and above 9 masks that are 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 quality system parts) to the NIOSH document. Only after the review, document review and test are passed, will NIOSH issue approval documents.

Although the certification process seems very cumbersome, many service agencies consulted by reporters have stated that as long as manufacturers cooperate, they can generally pass the certification within two weeks. In view of the popularity of the business, some organizations even launched an “express service”, claiming that it only takes 3 working days from the complete submission of information and samples to the certification. However, the charges for such services are relatively high, generally ranging from 25,000 yuan to 30,000 yuan (only for CE certification). Under the normal process, applying for CE certification of personal protective masks requires a cost of about 15,000 yuan, and medical masks are offered at a higher price, ranging from 18,000 yuan to 22,000 yuan. The cost of the US FDA certification is higher than the CE certification overall, and the service fee alone is as high as more than 20,000 yuan, plus the fixed fee for applying for certification, overall it is expected to exceed 50,000 yuan.

Export chain

The spread of the new coronary pneumonia epidemic has led to a surge in demand for masks and other protective equipment. According to public reports, there are hundreds of millions of masks in the United States alone, and many countries have alleviated the shortage of masks through limited supply and export bans.

As a major mask-producing country, China has also recently provided masks and other protective materials to other countries through donations, exports, etc. to provide the necessary guarantee for its prevention and control of epidemics. But for some mask manufacturers and import and export trade manufacturers, the shortage of overseas masks is also a market opportunity not to be missed.

The owner of a customs declaration service company in Dongguan has been planning a mask export business recently. However, he chose to export to Southeast Asia and the Middle East, but the situation he learned in recent days is not very optimistic. “There are not many organizations on the market that can provide mask certification services in Southeast Asia and the Middle East. I heard that the standards are not low and it is more troublesome to operate,” he told reporters.

A person in charge of a certification service organization in Guangzhou said that at present, most organizations mainly provide certification services for the European Union and the United States, not only in Southeast Asia, but also in Japan and South Korea.

The reporter also communicated with the owner of an import and export trading company as a mask manufacturer. He has recently been looking for suppliers through various channels-including entrusting certification service agencies. Regarding the current situation, his expectations are very optimistic. “Demand is not to worry about. Now the price of masks in the European and American markets has been rising. Whether it is a trader or a producer, the profit is very considerable.”

However, he refused to disclose the specific profit rate data: “After all, it is medical protective materials. It always feels not very kind to earn this money, but we can guarantee that the goods are genuine and will not take the wrong way.”

In this atmosphere, the consultants of the certification service organization act very “direct”. As mentioned above, Ms. Su said that due to the recent surge in applications, some NB institutions in the EU have gradually stopped issuing certificates, which means that it will become more and more difficult to obtain CE certification, which will take longer and cost more. Will get higher and higher. “If you want to apply, you have to settle down today, otherwise you will miss this wave of quotes,” she admitted.

The new capacity is still mainly domestic

Recently, the concept of A-share masks has continued to strengthen, which has nothing to do with the rapid increase in overseas demand for masks. Some analysts pointed out that due to the gradual control of the domestic epidemic, new mask production capacity can be exported to fill vacancies in overseas markets, and for listed companies in the industrial chain, this is also a rare opportunity to boost performance.

However, through exchanges with several listed companies involved in the production of masks, a reporter from the Finance Association found that domestic production of masks—especially the newly added or newly put into production capacity, still meets the domestic demand for prevention and control.

Annunciation Bird (002154.SZ) is also currently engaged in a small amount of mask production business. The company said that the mask production is currently proceeding normally, and it mainly supplies domestically, and there is no export plan. Souyute (002503.SZ), who recently announced the production of masks, also said that there are currently no export plans. Zhongshun Jierou (002511.SZ) ‘s previously completed mask production line has now begun to ship. Dong Qi Zhou Qichao revealed that for the time being, it is still mainly domestic, and there is no export business. Lanfan Medical (002382.SZ) also revealed that the company’s medical protective gloves have received many foreign orders, but the masks that will be put into production will be given priority to domestic supply, and the export will not be considered until the domestic epidemic situation is controlled.

In this regard, a foreign trade practitioner revealed that considering the needs of domestic epidemic prevention and control, some listed companies converted masks actually in accordance with the requirements of the local government. After shipment, they must also accept a unified arrangement, and there is not much in the market sales link Autonomy. On the contrary, some small and medium-sized manufacturers that were originally engaged in the production of masks can fully expand the export business based on the benefits of the enterprise. “Most of these manufacturers were originally sold domestically, so they need to apply for certification abroad,” the source said.

However, the impact of mask export on the performance of listed companies in the later period cannot be ignored. A listed company director who has just added a mask business recently said that once the domestic epidemic situation is controlled, the new mask production capacity during the epidemic prevention period must find a market, so the company has begun to prepare for export.

👉 China CE mask supplier

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