首页|体外诊断试剂说明书编写常见问题解析

体外诊断试剂说明书编写常见问题解析

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体外诊断试剂说明书作为上市产品注册证的必要附件,不仅可指导用户正确使用,还具有展示产品性能的作用,同时也是监管过程中的关键依据和手段.目前说明书的编写存在一些共性的常见问题,需注册申请人关注.确保产品说明书的科学严谨与规范统一,对于指导用户准确无误地使用产品至关重要.
Precautions for In Vitro Diagnostic Reagents Labeling
The instructions for use of in vitro diagnostic reagents as an essential attachment to the product registration certificate not only guide users on how to properly use the product,but also serve to showcase the product's performance.They are also a key basis and means of regulatory oversight.Currently,there are some common problems in the preparation of instructions for use that require attention from applicants for product registration.Ensuring the scientific rigor and standardized uniformity of product instructions for use is crucial for guiding users to use the product accurately and without error.

In Vitro Diagnostic ReagentsInstructions for useComponentsCalibratorControlPrinciples of procedurePerformance

雷山、韩昭昭、吕允凤

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国家药品监督管理局医疗器械技术审评中心,北京 100076

体外诊断试剂 说明书 主要组成成分 校准品 质控品 检验方法 性能指标

2024

中国药物评价
国家食品药品监督管理局信息中心

中国药物评价

影响因子:1.09
ISSN:2095-3593
年,卷(期):2024.41(6)