[Discussion on Administrative Innovation of Medical Device in China and U.S]

Yue Min; Wengchi Lan; Bin Liu

doi:10.3969/j.issn.1671-7104.2018.03.014

[Discussion on Administrative Innovation of Medical Device in China and U.S]

Zhongguo Yi Liao Qi Xie Za Zhi. 2018 May 30;42(3):206-209. doi: 10.3969/j.issn.1671-7104.2018.03.014.

[Article in Chinese]

Authors

Yue Min¹, Wengchi Lan¹, Bin Liu¹

Affiliation

¹ Center for Medical Device Evaluation of CFDA, Beijing, 100081. ##Email#.

PMID: 29885130
DOI: 10.3969/j.issn.1671-7104.2018.03.014

Abstract

This article refreshes the innovative review approach of medical device in China at first. It proposes reference through presenting a series of existing review and approval of innovative medical device in U.S. as well as new tools and methods for supporting scientific review.

Keywords: administrative innovation; innovative medical device; medical device.

MeSH terms

China
Device Approval
Equipment and Supplies*
Inventions*