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Food and Drug Administration went to the special inspection of Sinopharm equipment
 2022/08/19

Mao Zhenbin, director of the Inspection Bureau of the State Food and Drug Administration, Wu Aijun, director of the Research and Supervision Department of the Device Registration Administration Department, Lu Aili, deputy director of the Beijing Food and Drug Administration, Li Hongjie, deputy director of the Haidian District Food and Drug Administration, and Li Xiuli, the deputy director of the group of ten The five-person inspection team went to the Shunyi warehouse of Sinopharm Instruments to carry out on-site inspection of the "five rectification" of medical devices.


The "five rectification" campaign started in March this year. The CFDA hopes to crack down on illegal behaviors of medical devices by carrying out this special action. The special campaign of "five rectifications" for medical devices focuses on rectifying five acts such as false registration declaration, illegal production, illegal operation, exaggerated publicity, and the use of unlicensed products. Through special rectification, we will further implement the main responsibility of enterprises, promote the construction of corporate integrity, strengthen popular science publicity and education, and play a role in social supervision, so as to promote the healthy and orderly development of the medical device industry.

Zhu Xuejun, deputy general manager of Sinopharm Instruments, made a report on the company's "five rectification" activities, introduced the self-inspection work of Sinopharm Instruments, and provided information on the first enterprises, product approval management, medical equipment classification and storage, and the temperature and humidity of cold chain products. The control alarm system and the quality monitoring and management measures of daily medical devices were introduced in detail, and the achievements in software and hardware construction since the company launched the third-party logistics of medical devices were reported. Afterwards, the superiors inspected the storage of medical devices in Shunyi's warehouse on the spot. The General Administration had an in-depth understanding of the daily operation of Sinopharm devices through questioning, inquired about the traceability of medical devices in the logistics system, and reviewed the specific implementation process.


Through this inspection, CFDA recognized the achievements made by Sinopharm in the standardized management of medical devices. As the largest specialized medical device operating company in the country, Sinopharm hopes to play a leading and exemplary role in compliance operation. Sinopharm will continue to ensure the quality of medical device circulation under the guidance of the State Food and Drug Administration and Beijing Food and Drug Administration, and promote the improvement of the quality awareness and overall quality level of the medical device industry.

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