Marketing authorization of medical devices in Chinafor SRO.pdf (467.15 kB)
Marketing authorization of medical devices in China
journal contribution
posted on 2023-06-09, 00:49 authored by Weifan Zhang, Rebecca Lui, Chris ChatwinChris ChatwinMedical 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.
History
Publication status
- Published
File Version
- Accepted version
Journal
Journal of Commercial BiotechnologyISSN
1462-8732Publisher
Journal of Commercial BiotechnologyExternal DOI
Issue
1Volume
22Page range
15-22Department affiliated with
- Engineering and Design Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2016-04-11First Open Access (FOA) Date
2017-01-30First Compliant Deposit (FCD) Date
2016-04-08Usage metrics
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