To ensure the safety and effectiveness of the products, clinical trials are required for the registration of Class II and Class III medical devices. The interviewed enterprises reflected that some clinical trial institutions lack enthusiasm, and the time-consuming and labor-intensive nature of clinical trials has led some enterprises to be reluctant to develop new products. The head of a medical device enterprise said that several new products of the enterprise were undergoing clinical trials, but none of the top-tier hospitals were willing to accept them. Although the state has issued relevant policies to encourage medical institutions to conduct clinical trials, most of them are merely principle-based regulations, with insufficient hard and positive incentives. Therefore, some hospitals believe that clinical trials are a contribution to enterprises and have little to do with their own development. At the same time, they are afraid of medical accidents. The mentality of "it's better to mind one's own business" makes medical institutions lack the motivation to conduct clinical trials together with enterprises. "Sometimes, one has to rely on personal connections to beg the hospital to do it." Clinical trials have strict requirements, and some tube services may take several years to complete.
Guo Yijun and Xie Yufeng believe that when some mature products are updated and replaced, or when technologies that have already undergone clinical trials in other countries are introduced, clear clinical exemption system regulations should be formulated, the clinical trial procedures should be classified and simplified, and the market application of products should be accelerated. Xie Yufeng introduced that in the past, some of the X-ray machines produced by the enterprise did not need to undergo clinical trials, and the products such as tube services were outdated and needed to be updated. Now, it is stipulated that clinical trials must be conducted, but the cost of clinical trials, which takes one or two years and costs several million yuan, has deterred the enterprise from launching new models.
