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【CODEX】医疗器械注册单元划分指导原则(1)

医疗器械注册单元划分指导原则

Guideline for Division of Medical Device Registration Units

 

本指导原则根据《医疗器械注册管理办法》(国家食品药品监督管理总局令第4号)和《体外诊断试剂注册管理办法》(国家食品药品监督管理总局令第5号)有关要求制定。注册单元划分着重考虑产品的技术原理、结构组成、性能指标、适用范围及体外诊断试剂的包装规格等因素。本指导原则包括有源医疗器械、无源医疗器械及体外诊断试剂注册单元划分的指导原则,并列举了有关注册单元划分的实例,部分要求需结合相关的注册技术审查指导原则或标准进行综合判断。

This Guideline is formulated according to the Provisions for Medical Device Registration (CFDA Order No. 4) and the Provisions for In-vitro Diagnostic Reagent Registration (CFDA Order No. 5). The division of registration units shall pay special attention to the product's technical principles, structure and composition, performance indicators, scope of application as well as packaging specifications of in-vitro diagnostic reagents, etc. This Guideline includes guidelines for division of registration units for active medical devices, passive medical devices and in-vitro diagnostic reagents, and lists examples for division of registration units. Some requirements shall be judged comprehensively in combination with relevant guidelines or standards for technical review of registration.

 

本指导原则是基于现行医疗器械注册申报工作实际情况制定的,随着法规体系的不断完善、科学技术的不断发展以及认知水平的提升,本指导原则相关内容也将适时进行调整。

This Guideline is formulated based on the actual situation of the current medical device registration application. Along with the constant improvement of laws and regulations system, the continuous development of science and technology as well as the promotion of cognitive level, this Guideline will also be modified timely.

 

一、有源医疗器械注册单元划分指导原则

I. Guideline for Division of Active Medical Device Registration Units

 

(一)技术原理不同的有源医疗器械原则上划分为不同的注册单元。

(1) Active medical devices with different technical principles shall be divided into different registration units in principle.

 

(二)技术原理相同,但产品主要结构、组成的不同对安全有效性有影响的相同种类有源医疗器械原则上划分为不同注册单元。

(2) The same kind of active medical devices with the same technical principle but different main structures and compositions which have effect on safety and effectiveness, shall be divided into different registration units in principle.



 


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