Press conference on strengthening quality control for medical supplies and improving market regulation

The Joint Prevention and Control Mechanism of the State Council held a press conference in Beijing on April 5 to brief the media on the measures taken to strengthen quality control for medical supplies and improve market regulation. April 7, 2020

China Quality Daily:

Companies are required to obtain CE marks before exporting masks to Europe, but we have noticed some netizens report that CE marks can be purchased now. Is it true? If so, how would you regulate it? What should a company do if it gets a fake one this way? Thank you.

Liu Weijun:

Thanks for your question. It is about quality certification, which is a professional concept, so I would like to introduce it first.

Quality certification refers to the certification activities carried out by certification bodies to prove that products, services or company management systems conform to standards or technical specifications. It plays an active role in ensuring the quality and safety of products and promoting international trade. It is roughly divided into two categories in China: compulsory and voluntary. Compulsory certification means the state stipulates that certain products must be certified before they can leave the factory to be sold, exported or used in business activities. This is done to protect the health and safety of the people and the environment. Those in the current catalog of products subject to China's compulsory certification are all directly related to consumers; examples include cars, mobile phones, laptops, air conditioners and washing machines.

I would like to highlight that medical masks, protective clothing and ventilators are all products subject to the requirements of medical device registration and management, which is specified by the medical products administration authority but not subject to compulsory certification. When it comes to voluntary certification, companies apply for a certification based on market needs on a voluntary basis.

To be precise, CE marking indicates admittance rather than authentication. According to the EU, products falling under the CE directives must have the CE mark affixed before entering the EU market for sale. The conformity assessment includes two aspects: for most products falling under the directives, a company can make declarations of conformity, and as long as it can attest that the products meet the requirements of the applicable directives, the company can affix the CE mark on the products and put them into the EU market. However, high-risk products must be certified by notified bodies that are appointed by European authorities before they can have the CE mark affixed.

In addition, there are also discussions about the U.S. FDA "certification." FDA stands for U.S. Food and Drug Administration, which gives approvals rather than certification. In nature, it is a registration and management system of the government, like those that many countries have in place for drugs and medical devices.

As you mentioned just now, there have been issues with the certification process for some products being exported. In China, the essence of quality certification is delivering trust and serving development. Therefore, validity and authenticity are the life of the certification system. It is the role of the State Administration for Market Regulation (SAMR) to supervise certification activities in accordance with the law and crack down on illegal activities.

For example, last year we investigated and punished 87 certification institutes for violations of relevant regulations, which account for 15% of the total organizations. Five of these organizations, which had serious problems, had their licenses revoked. In addition, we issued online warnings on two foreign organizations for conducting certification activities in China without permission from the government. We also strengthened inspections on certificated products sold online, removing about 17,000 products from shelves by the end of 2019, thereby safeguarding customers' interests. 

Since the epidemic outbreak, we have focused closely on investigating and punishing illegal activities and irregularities involving the certification of products used to fight the epidemic. Right now, we are handling cases involving the misuse of certification symbols and advertisements with false information about certification. The SAMR has placed great importance on these problems and has planned to carry out a special rectification campaign aimed against irregularities in the certification of goods for export. Recently, it has released a notice on carrying out a special campaign to regulate certification activities in the field of respirators, protective clothing and other anti-epidemic items. At present, local market regulation departments are launching special rectification campaigns, focusing on such illegal activities as forging, falsely using, buying and selling authentication certificates, conducting certification activities without permission or in a non-standard way, and illegal pricing in the certification activities. Some serious cases will be made public after the investigation is complete.

Just now you also asked where complaints should be lodged. We have both the 12315 hotline and the 12315 online platform to receive complaints and reports. In addition, I would like to say that we hope enterprises, the media and consumers can all take part in the supervision of certification activities actively and provide any tip-offs they may have. Thank you.

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