【栓塞微球器械注册评价问题探讨】。

Q4 Medicine

中国医疗器械杂志 Pub Date : 2025-03-30 DOI:10.12455/j.issn.1671-7104.240422

Xiangmei Zhang, Yidan Zhang, Xiaoqi Lian

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引用次数: 0

摘要

本文就栓塞微球的结构特点及临床应用作一综述。根据审评经验和现行监管注册审评要求，从给药属性、产品描述、非临床研究和临床评价四个方面分析栓塞微球作为医疗器械的注册审评关注点，以期为该类产品的研发和注册申请提供参考，提高注册申请效率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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[Discussion on Registration Evaluation Concerns of Embolic Microsphere Devices].

The structural characteristics and clinical application of embolic microspheres were summarized in this paper. According to evaluation experience and current regulatory registration evaluation requirements, registration evaluation concerns on embolic microsphere as medical device were analyzed from four aspects: administration attributes, product description, non-clinical studies and clinical evaluation, in order to provide references for the development and registration application of such products and improve the efficiency of registration application.

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来源期刊

中国医疗器械杂志 Medicine-Medicine (all)

CiteScore

0.40

自引率

0.00%

发文量

8086

期刊介绍： Chinese Journal of Medical Instrumentation mainly reports on the development, progress, research and development, production, clinical application, management, and maintenance of medical devices and biomedical engineering. Its aim is to promote the exchange of information on medical devices and biomedical engineering in China and turn the journal into a high-quality academic journal that leads academic directions and advocates academic debates.