Overview of China's Medical Device Market and Government Regulatory Agencies

China has now become the second largest medical device market in Asia, with a 14.9% annual growth rate in the period2002–2006. In 2011, the Chinese medical device market is expected to increase 69% compared to 2006 to reach a valueof $23.2 billion. As business development opportunities in China grow rapidly, having a comprehensive understanding ofgovernment regulations and quality standards is critical for medical device manufacturers who manufacture and sellproducts in China. This paper gives an overview of China’s medical device market as well as the background and requirements of medical device regulations. The State Food and Drug Administration (SFDA) in China regulates the manufacturers and producers of medical devices, pharmaceuticals, food, nutrition, and cosmetics products. It is also responsible for drafting and publishing laws and regulations on safety management and providing supervision of these industries. Registering in China is a complex process as new regulations and standards are consistently adopted and released. In this paper, we present an overview on product classification in China. We also look at the way SFDA is organized, product registration requirements, and tips related to product registration including documentation, certificates, and necessary agents. An introduction to and suggestions for conducting device clinical trials is given, as well as an overview of the current status of quality assurance.