ABSTRACT
China's medical device market is forecasted to have a value of US$23.2 billion in 2011 with strong growth in two-digit annual growth rate. China's regulatory system for medical devices is still in its rapid development phase, which unavoidably leads to a certain degree of difficulty to catch up on the latest regulatory requirement. Language can also be a major problem for foreign manufacturers as most of regulation and standard are in Chinese. Since 1999, China Food and Drug Administration (CFDA) has issued some guidance documents for application and reviewing, most of which are about how to prepare registration application documents for a certain kind of medical devices, and also includes how to conduct a clinical trial and how to write user manuals, etc. CFDA is responsible for supervision and administration of medical devices nationwide. China has National Standard and Industry Standard for medical device, including Mandatory standard and Recommended standard.
