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Zhongguo Yi Liao Qi Xie Za Zhi. 2017 Sep 30;41(5):374-376. doi: 10.3969/j.issn.1671-7104.2017.05.017.

[Analysis of Similarities and Differences between Guidance of Magnetic Resonance Diagnostic Devices Clinical Evaluation and Guidance of Medical Device Clinical Evaluation].

[Article in Chinese]

Author information

1
Center for Medical Device Evaluation, CFDA, Beijing, 100081.
2
Liaoning Medical Device Test Institute, Shenyang, 110179.

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.

KEYWORDS:

clinical evaluation; guidance; medical devices

[Indexed for MEDLINE]

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