University of Sussex
Browse
Marketing authorization of medical devices in Chinafor SRO.pdf (467.15 kB)

Marketing authorization of medical devices in China

Download (467.15 kB)
journal contribution
posted on 2023-06-09, 00:49 authored by Weifan Zhang, Rebecca Lui, Chris ChatwinChris Chatwin
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.

History

Publication status

  • Published

File Version

  • Accepted version

Journal

Journal of Commercial Biotechnology

ISSN

1462-8732

Publisher

Journal of Commercial Biotechnology

Issue

1

Volume

22

Page range

15-22

Department affiliated with

  • Engineering and Design Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2016-04-11

First Open Access (FOA) Date

2017-01-30

First Compliant Deposit (FCD) Date

2016-04-08

Usage metrics

    University of Sussex (Publications)

    Categories

    No categories selected

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC