China has now become the second largest medical device market in Asia, with a 14.9% annual growth rate in the period 2002-2006. In 2011, the Chinese medical devices market is forecast to increase 69% compared to 2006 to reach a value of $23.2 billion. As business development opportunities in China grow rapidly, having a comprehensive understanding of the government regulations and quality standards is critical for medical device manufactures who manufacture / sale products in China.

This paper gives an overview of China medical device market as well as the background and requirements of medical device regulations. The State Food and Drug Administration (SFDA) in China, founded on the basis of the State Drug Administration, regulates manufactures and products of medical devices, pharmaceuticals, food and nutrition products, and cosmetics. It is also responsible for drafting and publishing laws and regulations on the safety management and providing supervision of these industries. Registering in China is a complex process as new regulations and standards are adopted and released. In this paper, we presents product classification in China, the way SFDA is organized, product registration requirements, and tips related to product registration including documentation, certificates and necessary agents. Introduction and suggestions on conducting device clinical trials and current status of quality assurance are followed.