China Consumer News:

In order to export face masks to the European Union (EU) and the United States, Chinese companies are required to have CE accreditation or follow the FDA's registration procedures. However, many of them are not aware of this and do not know which organizations have appropriate qualifications. We have learned that many companies blindly went through agents to get accreditation. We have seen companies queuing up to obtain export accreditation. Some companies have even suffered losses from doing this. What measures will the State Administration for Market Regulation (SAMR) take to help Chinese companies solve these problems? Thanks!

Liu Weijun:

Thanks for your question. Indeed, China's pandemic prevention materials are playing an increasingly important role in the global fight against the COVID-19 outbreak, and there is a growing need around the world for them. Most of the pandemic prevention materials are medical equipment that is exported to markets in destination countries like the EU and the United States. Just as I said, products exported to the EU are required to meet the standards of the CE marking system, and products exported to the United States need to get FDA registration. The SAMR attaches great importance to the problems you just mentioned, and it will take active measures to facilitate the entry of Chinese products into European and American markets. We have compiled an accreditation information guide for exporting pandemic prevention materials such as face masks to the EU and the United States, which is available on the official websites and WeChat accounts of the SAMR and the Certification and Accreditation Administration of China. The guide includes relevant requirements for obtaining a CE mark and completing the FDA registration process. We hope that the guide will help Chinese companies to understand relevant requirements and resolve problems in a quick and direct manner. As I mentioned just now, some products have to get accredited by EU-approved organizations before they can enter the EU. The guide lists the names of organizations that are qualified to give such accreditation in China. In terms of medical equipment, Chinese companies are also required to meet the requirements of ISO13485, a global standard for medical devices. The guide also provides information regarding which organizations are able to provide such a certification. The guide will be continually updated in the future for the convenience for Chinese companies and to help them solve problems they encounter. 

In addition, I would like to take this opportunity to give Chinese companies a special reminder. First, they must seek out authorized accreditation organizations. China has over 600 approved accreditation bodies that grant accreditation in the fields of products, services and management systems. Of course, the accreditation services are not limited to export products. Relevant information is available on the official website of the Certification and Accreditation Administration of China. Companies must use authorized organizations for accreditation services. Be careful to not get duped by unqualified organizations.

Second, enterprises shall understand the market access policies of export destinations. There are some instructions in the guidebook, such as surgical masks exported to the EU being classified into two types: sterile masks and non-sterile masks. According to the EU regulations, a manufacturer can affix the CE marking to its non-sterile masks once it has prepared a declaration of conformity. As for the sterile surgical masks, manufacturers have to obtain a CE certificate from an EU-authorized organization if they want to enter the EU market. To export surgical masks to the United States, manufacturers shall, in line with the country's relevant regulations, apply on the FDA website and submit relevant papers. 

Third, enterprises shall carry out production and operation in accordance with the regulations of China and export destinations, and strengthen their product quality management. Exporters of medical materials shall obtain China's medical devices registration certificates and meet the quality standards of the importing country or region, as is clearly stipulated in a notice jointly issued by the Ministry of Commerce, the General Administration of Customs and the National Medical Products Administration. If any problem concerning product quality management occurs, such as one involving certification and evaluation, we must respond in a timely manner. Especially when there is false information and hype, we shall respond promptly and clear up misunderstandings. In so doing, we can not only protect the interests of enterprises, but also safeguard the reputation and image of Chinese products. Thank you.

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