Analysis of Similarities and Differences between Guidance of Magnetic Resonance Diagnostic Devices Clinical Evaluation and Guidance of Medical Device Clinical Evaluation
10.3969/j.issn.1671-7104.2017.05.017
- VernacularTitle:医用磁共振成像系统临床评价指导原则与通用指导原则的异同分析
- Author:
Pengfei YANG
1
;
Yanan WANG
;
Zhiyong SUN
;
Yong ZHANG
;
Zhaoyang MENG
Author Information
1. 国家食品药品监督管理总局医疗器械技术审评中心
- Keywords:
medical devices;
guidance;
clinical evaluation
- From:
Chinese Journal of Medical Instrumentation
2017;41(5):374-376
- CountryChina
- Language:Chinese
-
Abstract:
Clinical evaluation of medical devices plays an important role in the life cycle of medical devices. This paper introduces guidance of magnetic resonance diagnostic devices clinical evaluation and guidance of medical device clinical evaluation issued by CFDA. Their similarities and differences of the framework and content are analyzed, especially the definition, clinical evaluation methods and support data. By comparison, the clinical evaluation work of registration applicants can be more scientific and reasonable. At the same time, it can also be used for reference by the food and drug administration departments in evaluating the clinical evaluation of other products.
