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