血管夹产品技术审评要点探讨  

Discussion on Technical Review Points of Disposable Vascular Clip Products

作　　者：张晓光 李睿 张瑜 刘炳锐 ZHANG Xiao-guang;LI Rui;ZHANG Yu;LIU Bing-rui(Tianjin Medical Device Evaluation and Inspection Center,Tianjin 300191)

机构地区：[1]天津市医疗器械审评查验中心,天津300191

出　　处：《中国医疗器械信息》2024年第21期11-13,共3页China Medical Device Information

摘　　要：随着中国人口老龄化的加深,临床上血管外科疾病的发病率呈现逐年上升的趋势。同时,新材料、新方法、新技术产业革命推动了血管外科领域的快速发展,也衍生出很多临床应用上便于操作、风险较低且安全有效的医疗器械产品。血管夹产品在国内推行多年并广泛被临床医生所应用,但目前尚缺乏相关国家、行业标准以及相关产品的指导原则对产品的注册申报及产品质量管理进行有效规范,导致在临床应用及监管部门进行日常监督检查方面存在一定的风险与挑战。文章以一次性使用血管夹产品为例,以该产品安全性、有效性问题为导向,对该产品在注册申报资料中的综述资料、研究资料、临床评价资料等重点、难点问题进行探讨,以期便于产品的注册申请人顺利进行产品注册申报,同时也为医疗器械产品技术审评人员、监管管理人员提供一定的技术参考。With the increasing aging of the Chinese population,the incidence of vascular surgery diseases in clinical practice is increasing year by year.The industrial revolution of new materials,new methods and new technologies has promoted the vigorous development of vascular surgery,and many medical devices and products that are easy to operate,low risk,safe and effective in clinical applications have also been derived.Nowadays,vascular clamp products have been implemented for many years in China and widely used by clinicians.However,there is still a lack of relevant national and industrial standards and guiding principles of relevant products to effectively regulate the registration and application of products and product quality management,which easily leads to certain risks and challenges in clinical application and daily supervision and inspection by regulatory authorities.Taking the disposable blood vessel clamp product as an example,this paper,guided by the safety and effectiveness of the product,discusses the key and difficult issues such as the summary data,research data,clinical evaluation data,etc.in the registration application materials of the product,so as to facilitate the registration application of the product smoothly,and also provide a certain technical reference for the technical reviewers and supervisors of medical devices.

关 键 词：血管夹 技术审评 注册 申报资料 灭菌 一次性使用 

分 类 号：TH789[机械工程—仪器科学与技术] R543[机械工程—精密仪器及机械]