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【CODEX】脊柱后路内固定系统注册技术审查 指导原则(6-10)

六、产品技术要求

VI Technical requirements for the product

 

脊柱后路内固定系统产品的技术要求应按照《医疗器械产品技术要求编写指导原则》《医疗器械注册管理办法》及相关的规范文件、产品相关标准进行编写,要包括产品名称、产品型号/规格及其划分说明、性能指标、检验方法、术语、附件等相关内容,具体格式详见《医疗器械产品技术要求编写指导原则》附件。

The technical requirements for the posterior spinal internal fixation system products shall be written in accordance with “Guidelines for the Preparation of Technical Requirements for Medical Device”, “Measures for the Administration of Registration of Medical Devices” and related regulatory documents and product-related standards, including product name, product model/specifications and description of classification, performance indicators, test method, terminology, attachments and other related content. The specific format is detailed in the attachment “Guidelines for the Preparation of Technical Requirements for Medical Device”.

 

(一)产品名称

(I) Product name

 

产品名称应使用中文,并与申请注册中文产品名称相一致,名称应能涵盖所申请的所有组件,名称要符合相关的法规和文件要求。对于固定系统申报产品的通用名称可在其中体现使用部位、手术入路、主要组件等通用信息,如胸腰椎后路椎弓根钉固定系统、胸腰椎后路板棒内固定系统等。对于以组件申报的产品直接使用该组件的通用名称即可,如矫形棒、椎弓根螺钉、矫形板等。

Product name shall be in Chinese and be consistent with the Chinese name of the product under application. The name shall cover all the components under application, and comply with requirements of relevant regulations and documents. The generic name of the fixation system under application may include general information such as body parts for clinical use, surgical approach, and main components, for example, posterior thoracolumbar pedicle screw fixation system, posterior thoracolumbar plate-rod internal fixation system, etc. For the product to be registered as a component, the generic name of the component can be used directly, for example, orthopedic rods, pedicle screws, orthopedic plates, etc.



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