At present, novel coronavirus (COVID-19) pandemic is spreading. The global spread is testing the ability of every country to fight the epidemic. After the positive results of epidemic prevention and control in China, many domestic enterprises intend to promote their products to help other countries and regions jointly resist the epidemic. On March 31, 2020, the Ministry of Commerce, the General Administration of customs and the State Drug Administration of China issued a joint announcement on medical devices related to coronavirus epidemic prevention (such as detection kits, medical masks, medical protective clothing, ventilators and infrared thermometers), which stipulates that from April 1, exporters of such products must prove that they have obtained the registration certificate of medical devices in China And meet the quality standards of the exporting countries or regions. The customs can release the goods only after they are certified as qualified.
The joint announcement shows that China attaches great importance to the quality of exported medical supplies. The following is a summary of some problems that are easy to be confused when exporting to the European Union and the United States.
（1） About CE mark
CE is the European community. CE mark is the EU’s regulatory model for products listed in the EU. In the EU market, CE certification belongs to compulsory regulation certification. Whether products produced by enterprises within the EU or products produced in other countries want to circulate freely in the EU market, CE mark must be pasted to show that the products comply with the basic requirements of the new method of technical harmonization and standardization. According to the requirements of PPE and MDD / MDR, the products exported to EU should be labeled with CE mark.
（2） About Certificates
Pasting the CE mark is the last step before the product enters the market, indicating that all procedures have been completed. According to the requirements of PPE and MDD / MDR, personal protective equipment (such as class III personal protective mask) or medical equipment (such as class I medical mask sterilization) should be assessed by the notified body (NB) recognized by the European Union. The medical device CE certificate should be issued by the notified body, and the certificate should have the number of the notified body, that is, the unique four digit code.
（3） Examples of requirements for epidemic prevention products
1. Masks are divided into medical masks and personal protective masks.
According to en14683, masks are divided into two categories: type I and type II / IIR. Type I mask is only suitable for patients and other people to reduce the risk of infection and transmission, especially in the case of infectious diseases or epidemics. Type II mask is mainly used by medical practitioners in operating room or other medical environment with similar requirements.
2. Protective clothing: protective clothing is divided into medical protective clothing and personal protective clothing, and its management requirements are basically similar to those of masks. The European standard of medical protective clothing is en14126.
（4） Latest news
EU 2017 / 745 (MDR) is a new EU medical device regulation. As an upgraded version of 93 / 42 / EEC (MDD), the regulation will come into force and be fully implemented on May 26, 2020. On March 25, the European Commission announced a proposal to postpone the implementation of MDR by one year, which was submitted in early April for approval by the European Parliament and Council before the end of May. Both MDD and MDR specify the performance of the product to ensure the health and safety of users.
Post time: Jan-18-2021