[Research on the Management System of Medical Device Recognized Consensus Standards in USA].

Zhongguo Yi Liao Qi Xie Za Zhi

Institute for Medical Device Standardization Administration, National Institutes for Food and Drug Control, Beijing, 102629.

Published: February 2018

This paper gives a brief introduction on the development of recognized consensus standards, the recognition working procedure and the overview of medical devices recognized consensus standards in USA, and analyzes the experience of the recognition management system in USA, aiming at providing a reference for the improvement of the medical device standard management system in China.

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http://dx.doi.org/10.3969/j.issn.1671-7104.2018.02.011DOI Listing

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