With the rapid spread of COVID-19 abroad, the supply and demand of foreign protective equipment and other materials are becoming increasingly tight, and many countries have turned to my country for help. But at the same time, due to the rigid requirements of foreign testing and certification and other technical regulations, my country’s exports of protective equipment such as masks and protective clothing (especially masks produced by new companies during the epidemic) have been affected to a certain extent. Recently, in order to alleviate the tight supply and demand situation, some countries have taken the initiative to relax relevant technical requirements. In order to thoroughly implement the spirit of General Secretary Xi Jinping’s important speeches at the deployment meeting on coordinating the prevention and control of the new coronavirus epidemic and economic and social development and at the special G20 leaders’ summit, promote the steady growth of foreign trade, and increase the supply of epidemic prevention and control to the international market Regarding the strength of materials, the access analysis of protective equipment in major foreign epidemic countries is now as follows:
1. Testing and certification requirements of major developed countries and recent relaxation measures
strong>
European Union: The European Union divides medical devices into four major categories based on risk levels, ascending from categories I, IIa, IIb, and III. Medical masks, medical protective clothing, and goggles all belong to Class I medical devices. They must obtain EU CE (ConformiteEuropeene, French for “conforming to the EU”) certification and have a CE mark on the equipment and its packaging before they can be sold in the EU market. Enterprises need to send samples to the EU’s local NB (NotifyBody, a third-party notification agency designated by the EU, with a small number) for testing and certification. According to the certification process, the entire process takes 3-6 months. Civilian masks also need to obtain EU CE certification. After companies provide product type test reports and self-declarations, they can affix the CE mark and enter the EU market. According to the certification process, it usually takes 7-15 days. On March 13, 2020, the European Union issued an announcement allowing member states to purchase masks (including medical and civilian use) that are still in the certification and evaluation process during the epidemic, but they can only be used by medical workers and are not allowed to be circulated and sold in the market. Regulatory authorities have retained The right to carry out subsequent spot checks.
United States: The United States also conducts classified management of protective equipment. If medical masks must be registered and certified by the US FDA (Food and Drug Administration), companies need to send samples to the US FDA laboratory for testing and submit registration application materials. The whole process takes about 4 months. Civilian masks must obtain certification from the National Institute of Occupational Safety and Health (NIOSH) in the United States. Companies need to send samples to the NIOSH laboratory in the United States for testing and submit technical data. The whole process takes about 4 months. On March 2, 2020, the U.S. Department of Health and Social Services issued an announcement allowing civilian disposable filter masks to be used by medical institutions during the epidemic after applying to the FDA. On March 5, 2020, the United States announced that tariffs on imported masks and other medical supplies from China would be reduced from 25% to 0%. On March 17, 2020, the U.S. Centers for Disease Control and Prevention (CDC) released “Optimizing N95 Mask Supply Strategies: Crisis/Alternative Strategies”, pointing out that during the COVID-19 epidemic, when the supply of N95 masks is insufficient, the relevant countries listed in the table Masks produced according to standards can be used as a suitable substitute for N95 masks. These include masks produced using Chinese standards GB2626-2006 and GB/T18664-2002.
Japan: Japan also manages medical devices according to risk levels, and the risk level determines the approval route for the product. Taking medical masks as an example, manufacturers must register with Japan’s PMDA (Pharmaceuticals and Medical Devices Agency, an independent administrative legal person pharmaceutical and medical device comprehensive agency). The manufacturer must also provide relevant certificates or international certifications proving that the product has medical functions. Information that meets the standards of China, the United States, and the European Union generally meets the requirements. The process for manufacturers to apply for PMDA registration is lengthy, generally taking more than half a year. There are no registration and certification requirements for civilian masks. There are currently no relaxation measures.
South Korea: South Korea divides medical devices into four major categories based on risk levels. Unlike the EU, masks and protective clothing are Class II products in South Korea. Medical masks must obtain a Korean medical device registration certificate, and companies need to send samples to the local agency designated by the Food and Drug Administration in South Korea for testing and review. The entire process takes 6-9 months. There are no registration and certification requirements for civilian masks. On March 17, 2020, South Korea announced that it would reduce tariffs on imported masks from 10% to 0% from March 18 to June 30. In addition, the Korean Customs and the Food and Drug Safety Department have significantly relaxed the import customs clearance procedures for masks. For masks imported for relief, donation and corporate payment for employees, the Korean Food and Drug Safety Department recommends that import conditions be exempted from confirmation, and the Korean Customs also conducts minimum customs clearance review. to ensure rapid import.
It can be seen from the above that major developed countries classify and manage medical devices such as medical masks and medical protective clothing according to risk levels, and adopt relatively strict registration and certification and other access management. . Civilian masks and other supplies have relatively loose access requirements. As the epidemic develops, relevant requirements tend to be dynamically adjusted at any time.
2. Analysis of pros and cons after foreign countries relax access
1 On the other hand, major developed countries have relaxed access to protective equipment, providing opportunities for my country to expand exports of protective equipment and resolve excess production capacity., especially for some new protective equipment manufacturers, if they have not yet obtained relevant foreign certification, they can export first and then go through certification to reduce the time cost caused by certification.
On the other hand, relaxing access also gives opportunities to a very small number of criminals. In particular, protective equipment such as masks, protective clothing, goggles, and gloves are all illegally inspected for export (hazardous disinfectant supplies such as alcohol are subject to legal inspection). Except for exports to countries such as Sierra Leone and Ethiopia that have signed intergovernmental inspection agreements with China, In principle, China Customs does not conduct export inspections on them, and only conducts a low proportion of inspections at the port. The inspection content is mainly to see whether the name, specifications, etc. of the exported goods are consistent with the declared content. Under such circumstances, some manufacturing companies and individuals may be tempted to fish in troubled waters and take the opportunity to expand the export of protective equipment that is not up to standard in terms of quality and safety or even counterfeit and shoddy. In addition, some companies also misunderstand the measures to relax foreign access. When they do not have a comprehensive and in-depth understanding of the relevant access requirements or even misunderstand them, they believe that European and American countries do not need testing and certification requirements, and export blindly, resulting in subsequent notifications, Recalls and returns.
