With over 1.4 billion people and an emerging public healthcare system, China is one of the most attractive secondary markets for medical device manufacturers worldwide. The regulatory requirements mandated by the State Food and Drug Administration (SFDA) have been evolving. In this audio conference, our speaker discusses the background of SFDA regulatory requirements and explain the process of registering your product in China, including specific information on how the SFDA defines and classifies a medical device, the registration dossier required by SFDA, regulatory criteria for testing and clinical trials. The presentation also provides examples of what has helped companies succeed in achieving approvals, and discuss the latest trends in the China regulatory environment.
Successful Medical Device Approvals in China was presented by Janice Ma, Managing Director, with ChinaGate and aired June 19th, 2008. For more details, or to listen to a sample clip, please visit our site www.fxconferences.com
