乳腺三维超声容积成像系统注册技术审评要点

Key Points of Breast Three-Dimensional Ultrasound Volume Imaging System from Registration Evaluation

概述乳腺癌筛查的三种方法,提出了利用乳腺三维超声容积成像系统解决乳腺癌早期发现率低的方案。文章结合乳腺三维超声容积成像系统的出现背景及其特点,并根据《医疗器械注册管理办法》等相关法规,针对其与传统超声的区别从注册审评的角度提出了相应的审评关注重点,主要涵盖适用和可参考的注册审评指导原则及相关标准、产品的结构组成、独立软件/软件组件的研究、有效期和包装研究主要风险分析,为此类产品的技术审评搭建了框架,并供注册申请人编写注册申报资料参考。

This paper introduces three methods of breast cancer screening,puts forward a scheme that use The Breast Three-dimensional Ultrasound Volume Imaging System to solve the low rate of breast cancer early detection.It also introduces The Breast Three-dimensional Ultrasound Volume Imaging System’s background and characteristics.According to the relevant laws and regulations,aim at the difference between it and traditional ultrasound,analyze and research key points of The Breast Three-dimensional Ultrasound Volume Imaging System from the perspective of registration review,including applicable standards and evaluation guidelines,product structure and working principles,software research,period of validity and packaging research,major risks analysis.It provides a framework for the registration evaluation of these products,and reference for the applicant to prepare the registration application materials.