手机注册 邮箱注册
修改密码(手机验证) 修改密码(邮箱验证)
登录
  • 手机号/邮箱
    密码
    忘记密码?
    登录
  • 注册
  • English
资源
【CODEX】移动医疗器械注册技术审查指导原则(征求意见稿)

移动医疗器械注册技术审查指导原则(征求意见稿)

Guidelines for Technical Review of Mobile Medical Device Registration(Draft for Comments)

 

本指导原则旨在指导制造商准备移动医疗器械的注册申报资料,同时规范移动医疗器械的技术审评要求。

This Guideline is intended to guide manufacturers in preparing registration application dossiers for mobile medical devices and to standardize the technical review requirements for mobile medical devices.

 

本指导原则是对移动医疗器械的一般性要求,制造商应根据移动医疗器械的产品特性提交相应注册申报资料,判断指导原则中的具体内容是否适用,不适用内容应详述理由。制造商也可采用其他满足法规要求的替代方法,但应提供详尽的研究资料和验证资料。

This Guideline is the general requirements for mobile medical devices. Manufacturers shall submit corresponding registration application dossiers according to the product characteristics of mobile medical devices, and determine whether the specific contents in the guideline are applicable. Reasons for inapplicable content shall be explained in detail. Other alternative approach that meets the regulatory requirements may also be adopted by the manufacturer, but detailed research data and validation dossier shall be provided.


以上是免费内容,查看更多请付费
立即购买
返回