With the outbreak and spread of COVID-19, the demand for personal protection equipment (PPE) like masks, protective clothing, and ventilators continues to soar across the world, which has led a boom in the mask market. China, as a significant producer in the world, has also increased their stakes in the production of PPE products. Even though business opportunities for Chinese manufacturers were increasing however it also leads to a chaotic mask market. Recently, the issues of inferior quality masks exported to the Netherlands created enormous challenges for the mask manufacturers in China. Following the incident, the Chinese government immediately introduced policies aimed at regulating the export of PPE items, including masks. In this article, we will explain about the current domestic mask market within China and ways to identify mask manufacturers.
1. Current domestic mask market in China
The current mask market is crowded with manufacturers, large factories, or small factories, varied in scale and quality of produce. Whilst the new policy was introduced to control the quality of the exports, it also led to a rather sophisticated procedures for PPE exports. The mask intended for exports are categorised into civil, medical non-sterile, and surgical masks. The three types corresponds to different parameters, which are relatively complex. So we need to be careful while finding reliable ones among the manufacturers.
At present, there are four kinds of mask manufacturers in the market:
1.1 The original qualified old factory that had been producing PPE products prior to the outbreak of COVID-19. When COVID19 broke out in China, they obtained temporary licenses issued by the government to supply to the market.
1.2 New factories appearing during the outbreak, factories that were not in the mask industry before COVID19, yet held certain qualifications. They would have aseptic workshops or similar mask-making equipment, which can be modified to produce masks. Therefore, the government issued licenses to those manufacturers to allow for the modification of their production line. With government’s licenses, the factories are subject to strict quality control protocols. These factories includes the large, listed companies, such as BYD, Wuling and Gree.
1.3 Private enterprises and small workshops. The production environment of these factories is quite inferior or even has no dust-free workshop. These factories often produce products with no certificates nor outer packaging.
1.4 Middlemens are currently one of the “main forces” in selling masks in the market. Most of them run their business on Social Media and market their “products” through some images posted on their Wechat Moments. They often inform the buyers that they hold the stock in hand as well as the required two certificates (CE and FDA certificates). Some of them were merely forwarding message contents from other resellers that might even attached with falsified or fraudulent “certificates”. Even though some middlemen may actually in fact have stocks in hand, they however probably obtained their stocks from small workshops with no certificates and repackage the masks.
2. New Policy in China to Regulate Mask Industry on April 1
With the reported issues of inferior mask quality exported to the Netherlands, China's Ministry of Commerce has established and deployed working mechanisms across all departments to tighten the quality control of medical PPE products. The government enforced its new policy and cracked down the supply of fake and shoddy products, ensuring all products are being exported adhering to stringent quality control to protect the safety and wellbeing of global citizens fighting the pandemic. From April 1 onwards, enterprises intend to export new corona virus detection reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers shall provide to the customs authority written or electronic instructions, guarantee that the exported products have obtained the registration certificate of medical devices in China and meet the quality standard requirements of the importing countries (regions). The specific certificates required to be provided by the enterprise will be discussed in detail below. Such policies effectively regulate the increasingly profitable mask market, and greatly improved and maintained the quality of exported masks.
3. The pits we’ve encountered
3.1 Middlemen pretend to be factories: During the epidemic, masks were sold at high prices. Many netizens claimed to have seen an increase in posts about masks being offered on their Wechat Moments. They were most likely purchasing agents, therefore will not disclose where they obtain their sources. Most of these are middlemen, and most of the masks they sold are produced by small workshops without certificates. Some offered to help purchase the said masks from other countries. For instance, KF94 masks from South Korea which were recently popular on Wechat Moments. They often inform buyers that these masks offers the same protection standard as N95. Such “masks” are usually claimed to have come from Vietnam, Japan, the United Kingdom, or other places however, it is close to impossible to verify the authenticity of their words and the products. People with safety consciousness may consider asking for the two so-called certificates, however, it’s hard for people outside the industry to distinguish the good from the bad, because it’s fairly easy to forge those certificates. Therefore, we recommend against the purchase of these products if you're overseas and you are not familiar with the person you're dealing with.
These middlemen works in multi-layered system where information transfer is exceptionally fast. Often when you ask for a mask, the information may had gone through the entire China among these middlemen. Middlemen often don’t have actual goods in hand. What they resell is usually the information about masks. As the information are being transferred, the price of face masks increases by folds. So buyers must learn to distinguish the middlemen from the real manufacturers. They may very likely disappear just the next moment when your payment is made.
3.2 What you see is not what you get In addition to middlemen, there is also what we regard as "small workshop masks". They are made by those manufacturers who do not have any qualified machines, nor are they standard mask manufacturers. Yet they can produce “masks” somehow. This kind of mask is popular not only on Wechat Moments but also on e-commerce shopping websites like AliExpress, Shopee, Amazon and Shopify. The photos they publicised in the Wechat Moments may even be a complete copy of the product pictures uploaded by genuine manufacturers. So it’s much harder to distinguish the differences. What will most likely happen is when receiving your delivery, you would be shocked by the “thin as cicada wings” masks.
What’s more, some middlemen would buy a large number of masks and repackage them, giving them a brand new look. The masks appears well packaged while in fact they were repackaged, while not only the mask but also, their packaging boxes were obtained from small workshops as well. They have neither product quality certificate nor CE and FDA certificates. Some of them may have certificates that have certain part of the certificate sensored, which are probably stolen from other manufacturers, or simply fake ones.
In short, we recommend against buying masks directly on Wechat or E-Commerce websites. You can choose to place an order directly with the manufacturer or find a reliable agency to help you, so as to avoid unnecessary economic losses.
3.3 Fraudulent Certificate During the COVID-19 outbreak in Europe, there has been an exponential increase in the demand for CE certification issuance within a short period of time. This is mainly because it enables manufacturers to receive order and trader to export from China and import into the European countries. In other words, the CE certificate of masks is the determining factor for businesses targeting the European market.
Currently, there are a variety of CE certificates in the market, which is so sometimes confusing. However, recent news has revealed that some CE certificate issued to mask manufacturers are not valid, because the license issuing organizations do not have the authorization scope to issue certification for mask production. There are a handful of organizations authorized by the European Union to be able to conduct certification activities in mainland China for such certification. With the increase in certification demand due to COVID19 global pandemic, the cost for certification has increased significantly from several thousand Chinese Yuan before the outbreak to tens of thousands of Yuan now.
In the following part, we will discuss about how to verify the authenticity of the CE certificate and how to distinguish whether it has EU authorization.
3.4 Postponed Delivery Even if the manufacturer has the corresponding qualifications and has both the CE and FDA certificates, there may still be problems ahead. For example, when you place an order, the manufacturer accepts the money, yet still tells you that it is out of stock. And the delivery is to be delayed for a long time due to limited capacity, which is reasonable but proven costly for buyers. Therefore, when placing an order and signing a contract, be sure to indicate the time of delivery to avoid such a problem.
4. How to Distinguish Reliable Mask Suppliers from the Unreliable?
4.1 How to identify whether the manufacturer has the qualification? Qualification is undoubtedly the first threshold for choosing a mask manufacturer. If there is no qualification, you can pass it directly. But even if they have the qualification, you need to double-check it, making sure they did not lie to you.
4.1.1 Check whether the certified company entity is consistent with its production entity. Many non-qualified manufacturers will use qualifications from other factories, misleading buyers to obtain orders. If the certified company entity is not consistent with the production entity, we can assume that the production entity does not have production qualification. If there is an additional production site for a certification subject, it must be put on record again, and the new production site will be added in the brackets after the qualification certification.
4.1.2 Detailed production data check The masks for formal customs export require the factory to provide all production documents, including business licenses, medical equipment production licenses, and other internal materials. Usually, these documents are unavailable to outsiders. Besides, some manufacturers declare exports through other channels. However, it is worth noting that even if the mask are being delivered the hospital or medical institutions by whichever means, should there be quality issues with the masks, the manufacturer and exporter can be found after tracing the source layer by layer, and prosecuted. Therefore, we advise you never to take risks, especially when the government had already stepped up on cracking down illegal masks exporters.
Now you can also check the list of related P materials registration companies on the official website of the Ministry of Commerce of the PRC. The query URL is as instance, a foreign buyer may contact a domestic manufacturer, who met all aspects of the qualification, and the certification was authentic. However, when the documents with the stock are being processed for customs clearance, they later found out that the qualification certification had expired a day prior. Eventually, the products fail to pass customs clearance, causing the buyer to sustain significant loss in the deal.
Qualification and materials required by domestic export trade enterprises at present:
1.Business license (business scope has relevant business contents)
2.Enterprise production license (manufacturing company)
3.Product inspection report (manufacturing company)
4.Medical device registration certificate (not required for non-medical)
5.Product manual (provided with the product), label (provided with the product)
6.Product batch / No. (outer packaging)
7.Product quality safety book and certificate (provided with the product)
8.Product sample picture and outer package picture
9.The trading company must obtain the registration of the consignee and consignor of the CustomsNow you can also check the list of related PPE products registration companies on the official website of the Ministry of Commerce of the PRC. The query URL is as follows: http://www.mofcom.gov.cn/article/b/e/202003/20200302950371.shtml
Therefore, we highly suggest that buyers delegate these work to your trusted agencies since it’s significantly harder for you to verify all these documents if you’re aboard.
4.2 How to judge the quality of products As for the quality of masks, it’s difficult to judge whether it is good or not. Take protective masks as an example. They are all called KN95, with both CE and FDA certificates. Some are 5 or 6 Yuan, while some are 10 Yuan, how would you choose? For disposable masks, some are more than 2 Yuan, while some are 1 Yuan or so, which one should you choose?
Here we must remind you that the medical mask is second to drugs. Therefore, the protective mask shall have the production qualification of protective articles, and some must have the production qualification of special protective articles. We divide the masks into two categories: medical masks and protective masks, however we will use the same method to determine the quality of each of them.
4.2.1 Manufacturer’s qualification in China This refers to the manufacturer’s production license, of course, including ISO certification and other certifications. However, medical masks can only be produced by manufacturers of Class II medical devices qualification. The basic conditions include IS08-level clean workshop (level 100.000), with sterilization equipment (also known as disinfection equipment), and the materials used must be medical grade melt-blown cloth. Manufacturers shall obtain production licenses and registration certificates for Class II medical devices. Nevertheless, masks produced by such manufacturers must be in line with the standard of the medical masks, subject to national supervision. The price gap among these factories will be about 10%.
Manufacturers without the above qualifications are generally called civilian mask enterprises. It does not mean that its quality must be poor. But their products shall have some limits. For example, they are prohibited from using the word "Medical Masks" on the masks and boxes (unless specially approved for emergency), even if its quality is up to standard. EU CE Class II and FDA 510k are corresponding to the qualification of Chinese medical masks, both of which are also the certification of Class II medical devices. Currently, the factories with EU CE Class II and FDA 510k certification are limited in number. Manufacturers more often only obtained Class I and FDA registration.
4.2.2 China test report There are two kinds of test reports for medical masks. One is 95% filtered, which we usually call it disposable medical masks. Its corresponding national standard is YY/T0969-2013. The other is YY0469-2011, which corresponds to a 99% filtering rate as well as sterilization needs. The national standard for protective masks is GB-2626. And there is a higher level of national standard, which is the medical protective standard, GB-19083. The enterprise qualification is issued by the national department, which is authentic and reliable. However there may be gray areas in the product test report. It may be tested by the National Authoritative Testing Agency or by an ordinary third-party laboratory. Therefore, when checking the test report, remember to see whether it is issued by the National Authoritative Testing Agency. Of course, you need to check its corresponding test data. To make sure if the testing organization is authorized by the CNAS (China National Accreditation Service for Conformity Assessment), you can check it on its official website and the web address are as follows: https://www.cnas.org.cn/english/photonews/03/902316.shtml
5 How to Verify the Authenticity of CE & FDA Certificate?
5.1 Query on its official website of the notified body Generally, EU certification authorities will allow for querying certificates on their official websites. After logging into the official website, there will be a certificate query page. You can enter the manufacturer’s English name, the certificate number, and other information to check whether there is a matching CE certificate. If so, it may be an authentic certificate. However, whether such CE certificates meet the certification standards of the EU still needs to be examined.
5.2 Query from official website Based on the Chinese standard the masks for export are divided into civil, non-sterile medical, and medical surgery, which corresponds to different parameters. First, confirm whether the mask belongs to the medical device category. Masks are divided into medical masks (which includes non-sterile medical and medical surgery) and protective masks. Exports to Europe and the United States must comply with the relevant regulations.
Second, you need to verify the certifications on the website. For FDA certification verification, it’s simple as it has one single official website: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
Enter the information needed, and check whether the provided certification matches or not.
For CE certification, it is a bit complicated, with medical masks and personal protective masks need to comply with different regulations.
Medical masks Through the official website of the European Union, we can see that there are 56 notified bodies authorized by the MDD 93/42/EEC Medical Device Directive. The detailed list of institutions, the NB number, and the scope of their qualified products are listed in detail. Inquiry address of institutions authorized by MDD 93/42/EEC on EU official website: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13
Since May 26, 2020, the MDR (EU) 2017/745 medical device regulation will officially replace the current MDD medical device directive in the European Union. They are also available on the EU official website of the European Union. There are currently only 12 notified bodies with MDR authorization. Inquiry address of institutions authorized by MDR (EU) 2017/745 on the EU official website: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
Personal Protective Mask Personal protective masks do not belong to medical devices, and they do not need to meet the requirements of EU medical regulations. CE certification can be completed according to the PPE personal protection directive. Currently, there are 112 notified bodies authorized by PPE personal protection directive on the EU official website. Inquiry address of institutions authorized by PPE on the EU official website: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501
Therefore, if the CE certificate issuing agency is not within the specific scopes, it means that it does not have the qualification to issue such certificates. Unfortunately, we have to say the “CE certificate” you have is invalid. So be especially careful with all these provided certificates and do verify their validity.
6 Freight Arrangements
Some countries support the export of PPE materials with charter flights, and here we explain briefly about charter flights.
First: Give the accurate information of the goods (such as the number of pieces, box gauge, volume, gross weight, etc.) Second: Confirm the accurate delivery time in advance (the time of delivery to the airport) Third: According to the above information, confirm the type of charter Fourth: Sign a contract, and pay a deposit in advance, 50% of the charter cost Fifth: Before transferring the aircraft to the designated airport for delivery, all the balance must be settled
In summary, when exporting masks or other PPE from China, ensure you're up-to-date with the procedure and know your certificates well. We hope this article will help. Thank you for your continued.
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