矫形器的医疗器械监管分析  

Analysis on Medical Device Supervision of Orthoses

作　　者：方新[1] 

机构地区：[1]北京社会管理职业学院,北京市101601

出　　处：《中国康复理论与实践》2016年第6期737-740,共4页Chinese Journal of Rehabilitation Theory and Practice

基　　金：民政部中央级项目委托科研课题

摘　　要：目的探讨矫形器的医疗器械监管需要解决的关键问题以及对市场的影响。方法辨析矫形器的含义,揭示监管现状,设计矫形器通用名称,分析监管对不同矫形器市场主体的影响。结果矫形器在康复辅具和医疗器械领域的不同含义给医疗器械监管造成困难。科学的命名和分类是解决困难的有效途径。结论矫形器产品链上的所有机构都在医疗器械监管范畴之内。矫形器装配机构在取得民政部门资格认定的同时,还应接受食品药品监督管理部门的监管。在医疗器械监管方面,需要进一步妥善解决个性化定制矫形器的监管难题。Objective To discuss the key problem of medical device supervision of orthoses and its effect on orthoses market. Methods The meaning of orthoses was discriminated, the status of regulation was revealed, the generic names of orthoses was designed, and the effect of supervision on different body of orthoses market was analyzed. Results Difficulties are brought to the medical device regulation because of different meanings of orthoses in the fields of assistive devices and medical devices. Scientific classification and naming was the right way to solve the problem. Conclusion All the organizations on chains of orthoses are within the category of medical device supervision. Fit- ring organizations of orthoses should also accept regulation of China Food and Drug Administration, at the same time gaining qualification from China Ministry of Civil Affairs. The problem of personalized orthoses supervision needs to be solved properly.

关 键 词：矫形器 医疗器械 康复辅具 

分 类 号：R49[医药卫生—康复医学]