The detection capacity is insufficient and there is a serious traffic jam
The registration of medical devices begins with product registration inspection. In recent years, relevant departments have also been strengthening the construction of medical device inspection capabilities. However, Xie Yufeng, the general manager of Beijing Wandong Medical Technology, and Guo Yijun, the general manager of Chongqing Xishan Technology, among others, pointed out that due to the wide variety of medical devices, especially the lack of testing equipment, personnel and standards for innovative products, as well as the cancellation of testing fees, the number of enterprise applications is large, and the phenomenon of "traffic jam" in registration and testing is relatively serious. Beijing Wandong is engaged in the production of imaging medical devices, the research and development of tubes, and diagnostic services.
Xie Yufeng introduced that only a dozen or so national laboratories can conduct electromagnetic compatibility testing, and only a few have large computer rooms. They are simply too busy to handle it all and have to queue up a year in advance. Furthermore, the free inspection has not alleviated the burden on enterprises. Instead, the congestion has been further exacerbated due to the numerous applications from various enterprises. This has also led to a lack of enthusiasm among testing institutions, and the phenomenon of leaving work on time is quite common.