Marketing authorization of medical devices in China

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

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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.

Item Type: Article
Keywords: medical device, regulation, China, medical device market, regulatory frameworks
Schools and Departments: School of Engineering and Informatics > Engineering and Design
Subjects: H Social Sciences > HF Commerce
J Political Science > J General legislative and executive papers > J0080 United States
J Political Science > J General legislative and executive papers > J0100 Other regions and countries
J Political Science > J General legislative and executive papers
R Medicine > R Medicine (General)
R Medicine > R Medicine (General) > R856 Biomedical engineering. Electronics. Instrumentation
T Technology > TK Electrical engineering. Electronics Nuclear engineering > TK4001 Applications of electric power
Depositing User: Chris Chatwin
Date Deposited: 11 Apr 2016 10:54
Last Modified: 07 Mar 2017 06:28
URI: http://sro.sussex.ac.uk/id/eprint/60394

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