我国医疗器械注册技术审查指导原则现状探讨

Discussion on the Status Quo of Guiding Principles for Medical Device Registration and Evaluation in China

目的:医疗器械注册技术审查指导原则作为审评的重要技术文件,是提高注册申报质量和技术审评一致性的有力抓手,对我国指导原则现状进行梳理归纳以供医疗器械相关人员参考。方法:对我国指导原则发布数量、覆盖情况、编制现状等进行概述、剖析存在的问题。结果与结论:我国指导原则的编制需要从数量、质量和产品覆盖率等多方面考量,以满足我国医疗器械行业的迅猛发展。

Objective:The guiding principle for medical device registration and evaluation is an important technical document for reviewers in China,which is a powerful tool for improving the quality of registration and evaluation.To summarize the current status of guiding principles in China for the reference of medical device related personnel.Methods:This article summarizes the number,coverage and current compilation status of guiding principles in China,and analyzes the existing problems.Results and Conclusion:The compilation of China’s guiding principles needs to be considered in terms of quantity,quality,and product coverage to meet the rapid development of China’s medical device industry.