我国体外诊断试剂产品注册管理现状分析

目的：对体外诊断试剂产品中注册管理相关法规和技术文件进行梳理、总结和分析，有利于从业人员和监管人员全面掌握注册制度的关键环节和配套要求，提升体外诊断试剂产品监管的科学性、准确性，提高企业开展相关产品注册的效率和质量。方法：从监督管理变化视角对注册管理办法的产品分类规则、执行标准、临床评价、审查指导原则、特殊审批程序等监管内容进行解读，分析体外诊断试剂行业的前景与面临的问题，阐释修订后的法规在保证体外诊断试剂安全有效、质量可控方面起到的明显成效。结果与结论：通过对体外诊断试剂产品注册管理法规进行修订，实现了对分类规则的调整，解决了部分产品分类与其风险不匹配等问题，完善了产品执行标准，使标准发挥出技术支撑作用，贯彻落实企业主体责任，加大临床试验管理力度，发布审查指导原则，补充特殊审批条件，在保证体外诊断试剂的安全、有效、质量可控方面发挥了显著作用，对我国体外诊断试剂整体行业的发展产生了深远影响。

Analysis of the Current Situation of Registration and Management of in vitro Diagnostic Reagents in China

Objective: This article has sorted out, summarized and analyzed relevant regulations and technical documents on registration management of in vitro diagnostic reagents, which is helpful for practitioners and supervisors to fully grasp the key links and supporting requirements of the registration system, improve the scientifi c and accurate supervision of in vitro diagnostic reagent products, and improve the effi ciency and quality of enterprise product registration. Methods: From the perspective of changes in supervision and management, this paper interpreted the product classification rules, implementation standards, clinical evaluation, review guidelines, special approval procedures and other regulatory contents, analyzed the prospects and problems faced by the IVD reagent industry, and explained the significant effects of the revised regulations on ensuring the safety, eff ectiveness and quality control of IVD reagents. Results and Conclusion: Through the revision of IVD product registration and management regulations, the adjustment of classifi cation rules was realized, and some problems such as the mismatch between the classifi cation of some products and their risks were solved. Improve the implementation of product standards, play the technical support role of standards; implementing the main responsibility of enterprises, strengthening the management of clinical trials, issuing guidelines for review, and supplementing special approval conditions have played a signifi cant role in ensuring the safety, eff ectiveness and quality control of IVD reagents, and have a far-reaching impact on the development of the overall industry of in vitro diagnostic reagents.