我国体外诊断试剂标准现状分析及思考

目的：为我国体外诊断试剂标准化建设提出相关建议。方法：总结分析我国体外诊断试剂标准化建设及标准体系结构，重点挖掘目前标准化工作与行业发展不适宜的内容，并提出针对性建议。结果与结论：近年来，我国体外诊断试剂行业发展迅猛，国家出台了一系列法规政策，以推动体外诊断试剂行业有序发展。体外诊断试剂在我国分属药品和医疗器械两类，标准体系也分为两部分，相应的标准法规已基本建立健全。但是，目前我国体外诊断试剂标准体系存在标准相对滞后、缺乏强制性标准、一些新兴技术产品尚无标准等问题。需进一步优化体外诊断试剂标准体系，完善标准组织管理并加强标准执行能力，以便更有力地推动我国体外诊断试剂整体质量水平的提升。

Analysis and Thoughts on the Status of in vitro Diagnostic Reagents Standards in China

Objective:To provide suggestions for the establishment of standardization system of in vitro diagnostic (IVD) reagents in China. Methods:The standard framework and establishment of the standardization system of IVD reagents in China were summarized and analyzed. Current contents of the standardization system unsuitable for the development of industry were mainly analyzed and the corresponding suggestions were provided based on these analysis. Results and Conclusion:In recent years, the IVD reagents industry of China has developed rapidly. Chinese government has implemented a series of regulations and policies to promote the orderly development of IVD industry. IVD reagents in China belong to two categories:medicines and medical devices. The standardization system of IVD reagents is divided into two parts accordingly. Although the corresponding standard regulations for IVD have been basically established and improved in China, there are some problems in the IVD reagents standardization system, such as relatively backward standards, lack of mandatory standards, and absence of the standard for some emerging technology products. It is necessary to further optimize the standardization system of IVD reagents, improve the organization and management of the standards and strengthen the ability of standard implementation so as to more effectively increase the overall quality level of in vitro diagnostic reagents in China.