手指关节康复训练器械的技术审评要点
Discussion on Technical Evaluation of Finger Joint Rehabilitation Training Device
程卫 1李岱岳 1张燕南 1耿燕 1杜志斌 1袁丽华 1宁彤1
作者信息
- 1. 河北省药品审评中心 (河北石家庄 050000)
- 折叠
摘要
该研究基于医疗器械安全性和有效性审查原则,概述了手指关节康复训练器械产品的结构组成、工作原理、预期用途、作用机理等,参考相关技术标准和指南文件,结合技术审评实际工作及已上市同类产品情况,对手指关节康复训练器械产品的技术审评要点进行研究,同时分析了手指关节康复训练器械产品的安全风险和有效性指标,以期为注册申报资料的撰写和技术审评尺度的统一,以及产品设计开发和企业注册申报提供参考和借鉴.
Abstract
This study is based on the principles of medical device safety and effectiveness review,summarizing the structural composition,working principle and intended use of Finger Joint Rehabilitation Training Device.By referring to the relevant technical standards and guidelines,combined with the actual technical review work and similar products,it analyzes and discusses the key points of Finger Joint Rehabilitation Training Device,and analyzes the safety risks and effectiveness indicators of Finger Joint Rehabilitation Training Device,in order to provide reference and lessons learned for the harmonization of technical review metrics.
关键词
手指关节康复训练器械/技术审评/审评要点Key words
Finger joint rehabilitation training device/Technical review/Review points引用本文复制引用
基金项目
2022年度河北省药品监督管理局科技计划项目(2022ZC1010)
出版年
2024
NETL
NSTL
万方数据