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  • JCB_2016_Zang_Liu_Chatwin

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Marketing authorization of medical devices in China

Research output: Contribution to Journal/Magazine › Journal article › peer-review

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Marketing authorization of medical devices in China. / Zhang, Weifan; Liu, Rebecca Ru-Yuh; Chatwin, Chris.
In: Journal of Commercial Biotechnology, Vol. 22, No. 1, 2016, p. 15-22.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

Harvard

Zhang, W, Liu, RR-Y & Chatwin, C 2016, 'Marketing authorization of medical devices in China', Journal of Commercial Biotechnology, vol. 22, no. 1, pp. 15-22. https://doi.org/10.5912/jcb720

APA

Zhang, W., Liu, R. R-Y., & Chatwin, C. (2016). Marketing authorization of medical devices in China. Journal of Commercial Biotechnology, 22(1), 15-22. https://doi.org/10.5912/jcb720

Vancouver

Zhang W, Liu RR-Y, Chatwin C. Marketing authorization of medical devices in China. Journal of Commercial Biotechnology. 2016;22(1):15-22. Epub 2016 May 11. doi: 10.5912/jcb720

Author

Zhang, Weifan ; Liu, Rebecca Ru-Yuh ; Chatwin, Chris. / Marketing authorization of medical devices in China. In: Journal of Commercial Biotechnology. 2016 ; Vol. 22, No. 1. pp. 15-22.

Bibtex

@article{d2bdf8817b534bf7ae19cc95e8e4d807,
title = "Marketing authorization of medical devices in China",
abstract = "Medical device regulations across the globe have significant variations. The Chinese medical device market, like China's economy, is developing rapidly. This article reviews the medical device regulations in China and illustrates the major changes that have been recently implemented according to the new medical device regulations that came into force on the 1st June, 2014. Most regulatory research has focused on the US and EU medical device regulations with little written about the Chinese medical device regulations. The purpose of this article is to bridge the research gap and to introduce the Chinese medical devices regulatory environment to investors or companies who are engaged in the medical device market or doing business in China",
keywords = "Medical device, regulation, China, medical device market, regulatory frameworks",
author = "Weifan Zhang and Liu, {Rebecca Ru-Yuh} and Chris Chatwin",
year = "2016",
doi = "10.5912/jcb720",
language = "English",
volume = "22",
pages = "15--22",
journal = "Journal of Commercial Biotechnology",
issn = "1462-8732",
publisher = "ThinkBiotech",
number = "1",

}

RIS

TY - JOUR

T1 - Marketing authorization of medical devices in China

AU - Zhang, Weifan

AU - Liu, Rebecca Ru-Yuh

AU - Chatwin, Chris

PY - 2016

Y1 - 2016

N2 - Medical device regulations across the globe have significant variations. The Chinese medical device market, like China's economy, is developing rapidly. This article reviews the medical device regulations in China and illustrates the major changes that have been recently implemented according to the new medical device regulations that came into force on the 1st June, 2014. Most regulatory research has focused on the US and EU medical device regulations with little written about the Chinese medical device regulations. The purpose of this article is to bridge the research gap and to introduce the Chinese medical devices regulatory environment to investors or companies who are engaged in the medical device market or doing business in China

AB - Medical device regulations across the globe have significant variations. The Chinese medical device market, like China's economy, is developing rapidly. This article reviews the medical device regulations in China and illustrates the major changes that have been recently implemented according to the new medical device regulations that came into force on the 1st June, 2014. Most regulatory research has focused on the US and EU medical device regulations with little written about the Chinese medical device regulations. The purpose of this article is to bridge the research gap and to introduce the Chinese medical devices regulatory environment to investors or companies who are engaged in the medical device market or doing business in China

KW - Medical device

KW - regulation

KW - China

KW - medical device market

KW - regulatory frameworks

U2 - 10.5912/jcb720

DO - 10.5912/jcb720

M3 - Journal article

VL - 22

SP - 15

EP - 22

JO - Journal of Commercial Biotechnology

JF - Journal of Commercial Biotechnology

SN - 1462-8732

IS - 1

ER -