能量治疗类设备量效关系和能量安全研究资料要求概况及探讨
Overview and Discussion of the Dose-Effect Relationship and Energy Safety Research Data Requirements of Energy Therapy Equipment
申高 1常凤翥1
作者信息
- 1. 国家药品监督管理局医疗器械技术审评中心,北京 100076
- 折叠
摘要
量效关系和能量安全研究资料是能量治疗类产品注册申报资料中的非临床研究资料的组成部分,其对于评价产品的安全有效性起着重要的作用.本文通过对已发布指导原则中的相关内容进行梳理,从而明确光学、超声、射频、微波等各类能量治疗产品的特定要求,厘清量效关系和能量安全的概念,对能量治疗类产品的该部分注册申报研究资料提出细化的要求,以期为注册申请人及相关从业人员对相关内容资料的撰写提供帮助和指导.
Abstract
The non-clinical research data in the registration materials of energy therapy products,including dose-effect relation-ship and energy safety research data,are crucial for evaluating the safety and effectiveness of these products.This paper eluci-dates the specific requirements for various energy therapy products,such as optics,ultrasound,radiofrequency,and microwave equipment.It defines the concepts of dose-effect relationship and energy safety and proposes detailed requirements for the regis-tration research materials pertaining to these aspects.The aim is to provide assistance and guidance to registration applicants and relevant practitioners in submitting pertinent content materials.
关键词
能量治疗设备/量效关系/能量安全/研究资料要求Key words
energy therapy equipment/dose-effect relationship/energy safety/research data requirements引用本文复制引用
出版年
2024
NETL
NSTL
万方数据