"Currently, masks managed by medical devices in China are mainly divided into three categories: medical protective masks with the highest protection level, medical surgical masks used in invasive operating environments such as operating rooms and disposable medical masks used in ordinary environments..." On October 22, the reporter learned in the sichuan Province "Medical device safety" theme Open Day activity, according to the environment, the type of pollutant transmission and risk situation, to choose and wear the appropriate type of medical mask.

Activities on the same day, the provincial food and drug administration to invite medical equipment manufacturing enterprises, social organizations, news media, such as representative, entered the medical device testing center, sichuan province, sichuan province medical equipment technical review evaluation center, mike biological co., LTD., chengdu MingSen medical equipment co., LTD., to understand our province medical instrument detection ability, the development of medical instrument technical review and adverse event monitoring, as well as the new crown diagnostic reagents needed for epidemic prevention and control, surgical masks and other products of research and development, production and quality security situation.

"By the end of June 2020, the center has completed more than 800 batches of various emergency tests. We will use epidemic prevention materials for medical teams in Hubei, and carry out on-arrival and on-board inspection of emergency imported epidemic prevention materials to ensure that qualified products can be put into front-line use in a timely manner." The relevant person in charge of the Medical device testing center of Sichuan Province introduced the emergency testing launched during the coVID-19 outbreak. After learning about the coVID-19 emergency detection work, the delegates also visited various active and passive professional testing laboratories of the Provincial Medical device Testing Center, including the testing sites of medical masks, protective suits, infrared thermometers and other anti-epidemic medical devices of public concern.

Later, the delegates visited the r&d center and production plants of two medical device manufacturers, Mike Biological Co., Ltd. and Chengdu Minson Medical Device Co., LTD. In Mike Biological Co., LTD., the head of the company introduced the development and production of the first Novel Coronavirus detection kit, the novel Coronavirus2019-NCOV nucleic acid detection kit (fluorescence PCR) and the novel Coronavirus detection kit with direct chemiluminescence of the immune platform in Southwest China. In Chengdu Minson Medical Equipment Co., LTD., the company leader introduced the quality and safety guarantee of medical surgical masks in detail from raw material supply to clean workshop production, to product sterilization analysis, factory testing and sample retention management.

In the provincial Medical device Technology Review and Evaluation Center, the representatives had a further understanding of the technical review of medical devices and the monitoring of adverse events of medical devices in our province. At the same time, we also focused on the emergency review and on-site inspection of the medical equipment needed for the prevention and control of the epidemic. According to the relevant person in charge of the center, up to now, the center has carried out the technical review of more than 100 pieces of medical equipment for epidemic prevention and control, providing strong technical support for the province to continuously strengthen the guarantee and reserve of epidemic prevention and control materials.

It is understood that the "medical device safety" themed Open Day is one of the series activities of sichuan Province medical device safety Publicity Week this year, and it is also the first time for the public, production enterprises and news media to show our province's medical device products in the development and production, inspection and testing, review and inspection and other important process.

MAO Lixin, technical director of Sichuan Nangel Biotechnology Co., LTD, said that this visit to the testing center, technical review and evaluation center and manufacturing enterprises not only enables us to have a more direct understanding of the testing, evaluation and inspection procedures carried out by various agencies of the drug regulatory department, but also serves as a spur and requirement for ourselves. As a production enterprise, we must strictly comply with the requirements of the relevant national laws and regulations, the implementation of the main responsibility of the enterprise, improve product quality and management level, to ensure the quality and safety of the enterprise products, better protect the safety of people's equipment.