高电位治疗仪注册概况及审评要点探讨

Regisitration and Key Points Analysis of High Potential Therapeutic Apparatus

高电位治疗仪按照新版医疗器械分类目录,属于第三类医疗器械管理。文章从高电位治疗仪注册情况和审评关注的几大方面对该产品进行了梳理,为产品注册申请人和相关审评人员提供参考。

According to the classification catalogue of medical devices,high potential therapeutic apparatus is classified into the third category of medical equipment management.In this paper,registration and key points of high potential therapeutic apparatus are sorted out,as a reference for the registration applicants and relevant reviewers.