安徽省第二类医疗器械注册资料审评常见问题分析

Common problems analysis of the second category of medical device registration information in Anhui province

目的:探讨第二类医疗器械生产企业规范注册资料、提高注册效率问题。方法:对安徽省435个第二类医疗器械注册品种进行抽样统计分析。结果:找出了最容易及高频次出现的问题。结论:医疗器械生产企业严谨规范申报产品材料能提高注册效率。

Objective： To investigate standardized registration information of the second category of medical device production enterprise in order to improve the efficiency of registration. Methods： Sampling and statistical analysis of 435 second category of medical device registration varieties in Anhui province. Results： To find out problems most prone to high frequency. Conclusion： Efficiency of registration can be improved if medical device manufacturing en- terprises can strictly regulate the declaration materials.