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Chinese Journal of Medical Instrumentation ; (6): 305-308, 2018.
Article in Chinese | WPRIM | ID: wpr-689802

ABSTRACT

For medical device clinical evaluation activities, reference to international and domestic medical device regulations and guidance documents, this paper briefly introduces the implementation steps of clinical evaluation of medical devices, and focus on the evaluation report should be included in the content, provides reference for relevant personnel of medical devices registration and certification on medical device clinical evaluation practice.


Subject(s)
Humans , Clinical Trials as Topic , Device Approval , Equipment and Supplies
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