As there is a larger demand for medical maks, production has quickened. Most masks are made in China, in total at least 50% of global production. Therefore, importing medical masks from China is a big topic. According to WHO recommendations, to protect oneself from various diseases, one should wear a mask if taking care of a sick person and often wash hands with soap or use alcohol-based hand sanitizers.
The import of medical masks from China – production areas
The largest production hubs of surgical masks are in such Chinese cities as Wuhan, Ningbo, Suzhou, Guangzhou, and Hefei. Mask materials are manufactured mainly in four provinces: Guangdong, Zhejiang (Xialu), Hubei (Xiantao), and Fujian. Pengchang, located in Xiantao, is known as the “capital of fibers.”
It was estimated that up to 22 million masks were manufactured in China per day before the pandemic. As the demand increased, the factories intensified the production of masks, reaching 200 million per day. Besides, manufacturers from other industries have opened their production lines, contributing to increased supply. The masks are available in various sizes and colors; the standard ones are blue and white.
The import of masks from China – trade shows
Participation in trade fairs is an excellent opportunity for the importer to find a business partner. Also, such events make it possible to compare the offers of many producers in a short time. Below are examples of fairs where exhibitors present procedure masks and similar goods.
- China International Medical Equipment Fair
Location: National Exhibition and Convention Center, Shanghai, China
Official site: cmef.com.cn/g1225.aspx
About 200,000 participants attend the large-scale CMEF trade show. During the event, you will be able to find various types of face masks.
- China (Guangzhou) International Fire Safety and Emergency Equipment Exhibition
Location: Guangzhou – Poly World Trade Center, Guangzhou, Guangdong, China
Official site: cgiese.com/index.php?siteid=2
The CFE is the largest and most influential trade show in the industry in the south of China. The previous edition attracted 40,000 participants. During the 2020 edition, some of the 800 exhibitors will present surgical masks.
- China (Beijing) International Medical Devices Exhibition
Location: Beijing – China International Exhibition Center, Beijing, China
Official site: china-medexpo.com/beijing/english/index.asp
The fair focuses on all kinds of medical devices and equipment. Procedure masks are also among them.
In order to contain the spread of coronavirus, mass events, including trade fairs, have been postponed. We recommend that you check the official websites of the exhibitions you want to participate in.
The tariffs and the importer’s obligations in the US
The payment of customs duty is obligatory for every importer. The current rates can be easily found in the Harmonized Tariff Schedule System provided by the United States International Trade Commission. We advise you to get familiar with the guide first. The HS code of the disposable mask is 6307.90.98.70; the tariff is 7%.
Because of the US-China trade war, some goods imported from China to the US are subject to an additional tariff. The tariff rate on medical products was initially set at 15% but was lowered to 7.5%.
Medical masks – standards and regulations
Surgical masks, as a part of the medical gear, are tightly regulated in terms of applicable standards. When undertaking the import of masks from China, the importer must make sure they comply with those standards and regulations before being introduced to the market. Otherwise, your company might suffer losses.
The US Food and Drug Administration (FDA) regulates medical devices in the US market. Surgical masks are in class 2 of medical devices. The product is regulated under 21 CFR 878.4040. The FDA has drafted standards with which manufacturers have to comply. They are obliged to receive a license to sell the products on the market. In addition, the manufacturer has to indicate the use of the product on the package. You should choose a manufacturer with ISO 9001.
The masks are submitted to the same tests as the ones for the European market (standard EN14683). Moreover, the FDA prescribes the measurement of filtration efficiency regarding inert particles (latex) and fire tests. The US ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks describes the tests and requirements. The materials must comply with the standard. According to the results of several tests, the masks are classified into three levels. The product must meet the labeling requirements.
The tariff and the importer’s obligations in the EU
You can find the EU customs tariff in the Tariff of the European Union TARIC. It is available in multiple European languages and is user-friendly. The code for medical masks is 6307 90 98 10, and the tariff is 6.3%.
The importer’s obligation is to familiarize oneself with the product’s specifications and requirements on the target market. EN14683 is standard on the EU market that a medical mask has to meet. The mask must bear the CE marking. This product is considered a medical device. Therefore, it must be tested and comply with the regulations described in Regulation 2017/745. In addition, if the manufacturer has ISO 13485, it means that he maintains a high quality of medical products and they are manufactured in accordance with legal requirements. From 26 May 2020, this system will apply to all medical device manufacturers.
Attention! We remind you that you should have the other party that you are partnering with verified. We especially recommend caution when importing products that are in high demand. It is more likely that you come across a scammer in a popular industry who wants to take advantage of the situation. We’ve recently noticed an increase in Internet fraud connected to importing protective masks and coronavirus test kits from China. Verification of your new Chinese supplier is essential.