Full Of Dry Goods! Export Policy And Practical Interpretation Of Epidemic Prevention Materials Production

The global epidemic continues to ferment. In the face of the production gap of the relevant protective materials such as masks and other countries, the textile industry in the center of epidemic prevention materials, many Chinese textile enterprises shoulder the social responsibility, join the production teams of epidemic prevention materials, and actively carry out external epidemic support.

Since the outbreak of the epidemic, the China Textile Industry Federation and China Council for the promotion of international trade have also taken the initiative to give full play to their advantages and serve the overall situation. Recently, nearly 40 masks, protective clothing, goggles and other medical supplies manufacturing enterprises have been assembled, butted and approved. They have contacted 25 government departments and trade associations in 16 countries and regions, as well as 9 embassies and consulates in Shanghai. Docking, in order to alleviate the shortage of medical resources in all countries and fight against the epidemic, we can provide help in every way we can. With Chinese textile strength and wisdom, we will infuse "strong heart" into the fight against epidemic prevention and control.

In the process of docking between Chinese and foreign medical materials, some chaos caused industry concern. Many Chinese enterprises produce quality control materials, but export certification, especially the CE certification in Europe and the FDA certification in the United States and Canada, do not conform to the rules. The proportion of non-compliance is unexpectedly high, which has a negative impact on the export of Chinese anti epidemic products. In March 31st, the Ministry of Commerce and the General Administration of customs and the Drug Administration issued the announcement on the orderly export of medical materials (No. fifth in 2020), requiring that the 5 categories of products, such as test reagents, medical masks, medical protective clothing, respirators and infrared thermometers, must be qualified by the national drug regulatory authorities and meet the requirements of the import country (region) quality standards, and further strengthen the quality supervision. Regulate and standardize export order.

To help industry enterprises grasp the export and certification new policies in a timely manner, reduce the economic losses and legal risks of enterprises. On the afternoon of April 16th, the textile industry branch of the China Council for the promotion of international trade organized an online live lecture entitled "mask production, export of protective clothing, export policy interpretation and trade access practice". We invite experts from the Shanghai municipal market supervision and Administration Bureau, Shanghai labor insurance products association, Ying Bo Inspection Technology Co., Ltd. and Spain Textile Industry Research Association to interpret relevant policies, operation procedures and matters needing attention for different industries.

Agenda

Guest speaker

Speech by special guest

Shanghai market supervision and Administration certification and supervision department

Director Liu Chunyang

Current situation and Prospect of personal protective equipment market

Zhu Wenbin, Secretary General of Shanghai labour protection supplies Association

Medical masks, protective clothing, European and American market testing standards, market access

Mindy, senior lecturer in Ying Bo test

European market access and CE certification process for PPE respirators and protective clothing

Spanish Textile Industry Research Association Li Zhicheng

Liu Chunyang, director, certification and supervision department of Shanghai market supervision and Administration Bureau In the opening speech, it stressed that different countries have adopted different measures to deal with the import of medical materials. When docking, enterprises must understand the relevant laws and regulations of the exporting countries on medical materials in advance, and also fully understand and digest the newly issued "Announcement No. 5" in order to go smoothly.

Personal protective equipment has continued to be the focus of public attention during the epidemic. At present, there are some unaccredited certification bodies and intermediaries in the country that make use of enterprises' ignorance of EU laws and regulations to induce enterprises to entrust their agents with "certificate of authentication", which makes them face huge commercial risks and legal risks in the process of exporting to the EU. In this regard, Zhu Wenbin, Secretary General of Shanghai labour protection supplies Association It said that in response to the outbreak, the European Union issued recommendations on conformity assessment and market surveillance procedures for medical devices and personal protective equipment (PPE) during the epidemic. The proposal provides special access and market supervision requirements for respirators during the epidemic. In addition to the European Union, the US Centers for Disease Control and Prevention (CDC) has also released an optimized N95 mask supply strategy: Crisis / substitution strategy, which is not consistent with the current medical standard system requirements in the United States, but with the expected or known shortage of N95 masks, it can use KN100, KP100, KN95, KP95 types that conform to the Chinese standard GB2626, and FFP3 and FFP2 instead of N95 mask that conform to the European EN149 standard.

With the spread of the epidemic, the import policy of the European Union and the United States has been constantly adjusted. Many companies that have not yet been involved in related products have been testing water and encountered various problems in the export process. For this reason, it comes from Mindy, senior lecturer of Ying Bo Detection Technology Co., Ltd. The requirements for exporting to Europe and the United States are described in detail. She pointed out that the European export masks must be labeled with CE certification, and some of the assessments must be completed by the authorized announcement body, NB. In March 20th, the European Union also issued new regulations on emergency examination and approval. Medical masks and personal protective masks can be allowed to sell within a certain time even though their compliance evaluation is not completed, but the product must still complete the compliance evaluation process. But at the same time, the EU has also made clear that it will focus on the inspection of epidemic prevention products, so as to prevent unqualified products from causing serious risks.

Protective masks exported to the United States must be approved by the National Institute of occupational safety and health (NIOSH) before entering the United States. During the outbreak, it was in line with GB. 2626 the KN95 standard respirator can enter the United States as long as it meets any of the following conditions: first, the manufacturer has one or more NIOSH approved other masks, which can be produced in accordance with other national standards approved by FDA; two is the regulatory authority granted by the product outside China for FDA approval; three, the product test report should show the performance of the product with test standard requirements and report. The independent third party testing laboratory can be verified by FDA.

Last lecture, from Mr. Li Zhicheng, Spain Textile Research Institute The entry conditions of three levels of protective products entering the European market and the CE certification process are introduced in detail. The EU standard stipulates that PPE products can be classified into three grades: grade 1- low risk, grade 2- risk, grade 3- high risk according to different protection level. For Grade 1 protective products, manufacturers can authenticate and mark the corresponding CE labels. The products do not need to provide corresponding EC-Type certificates when entering the market. For grade 2 protective products, suppliers must provide corresponding standard technical documents, test reports and EC-TYPE certification certificates; for grade 3 protective equipment, suppliers must provide corresponding standard technical documents and test reports. EC-TYPE certification and production validation report.

The live broadcast has attracted nearly 5000 industry audiences to interact online. During the live broadcast, the industry audience consulted the online experts on the current export related problems and doubts of the epidemic prevention materials, and we all said that the lecture was organized at that time. The content is very practical and has strong practical reference value. In the future, the textile and Trade Promotion Committee will also carry out the services that can be done in time according to the needs of enterprises, so as to ensure the healthy and orderly development of the enterprises in the "special period".