Marketing authorization of medical devices in China

Zhang, Weifan and Liu, Rebecca Ru-Yuh and Chatwin, Chris (2016) Marketing authorization of medical devices in China. Journal of Commercial Biotechnology, 22 (1). pp. 15-22. ISSN 1462-8732

Text (JCB_2016_Zang_Liu_Chatwin)
JCB_2016_Zang_Liu_Chatwin.pdf - Accepted Version
Available under License Creative Commons Attribution-NonCommercial.

Download (499kB)


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

Item Type:
Journal Article
Journal or Publication Title:
Journal of Commercial Biotechnology
Uncontrolled Keywords:
ID Code:
Deposited By:
Deposited On:
22 Jun 2019 08:09
Last Modified:
22 Nov 2022 04:54