Xu Jinghe supervised and inspected the quality supervision of medical masks in Beijing

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On February 10, Xu Jinghe , Deputy Director General of the National Medical Products Administration, led an inspection team to the biomedical industry base in Daxing District in Beijing to conduct on-site inspection of Beijing Biosis Healing Biological Technology Co., Ltd., and supervise the supervision work of medical devices for COVID-19 pandemic prevention and control in Beijing.



Supervision inspection group entered into surgical masks production workshop and quality test area of Beijing Biosis Healing Biological Technology Co., Ltd., the field trip at the surgical masks all production processes, product raw materials, production and inspection equipment, infrastructure, sites, personnel, etc., focusing on the construction and operation of the quality management system. Subsequently, the supervision and inspection team listened to the introduction of the quality management of medical mask products by the leaders of the enterprises, and the report of the relevant leaders of the Beijing Municipal Medical Products Administration on strengthening the supervision of medical devices for COVID-19 pandemic prevention and control, and had in-depth exchanges with the enterprises and regulatory authorities.

Xu Jinghe  pointed out that the current COVID-19 pandemic prevention and control still can not  relax, surgical masks and other COVID-19 pandemic prevention and control of medical equipment production enterprise should earnestly implement enterprise's main body responsibility, organize production in strict accordance with the medical device laws, regulations, standards and technical regulations,, maintain a sound quality management system with effective operation, ensure the factory products continue to meet quality requirements, to continue to contribute to COVID-19 pandemic prevention and control; Drug regulatory departments to fully understand the new situation problems of COVID-19 pandemic prevention and control work, and resolutely implement the central committee of the State Council decision deployment, according to the market supervision administration, Medical Products Administration and other relevant departments work requirementsmake every effort to perform quality supervision on COVID-19 pandemic prevention and control medical devices such as surgical masks and others, ensure the quality and safety of COVID-19 pandemic prevention and control  medical devices.

Comrades from the medical device regulatory department of the National Medical Products Administration participated in the supervision and inspection.

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