Friday, July 25, 2008

Medical Device and IVD Registration in China

China represents an attractive market for many mutinational companies due to two key elements: the dense population and huge consumer base; and the country's rapid economic growth. Due to the government policy of economic regeneration and the urbanization reshaping most regions, Chinese people are gradually becoming more affluent. As a result, there has been exponential growth in the medical device and IVD market in recent years. This phenomenon is similar to the drug industry in the early 90's.

The market potential for these two sectors is simply tremendous. Although there are different predictions and calculations from various experts regarding the market size of the medical device industry, a conservative estimate is over five billion US dollars. China is already the number two player in the Asia market and is just behind Japan in terms of volume. But while the potential is attractive, the registration process for medical devices and IVDs in China is quite lengthy, and the regulatory hurdles significant.

This presentation will provide an introduction to the regulatory environment in China, and the requirements and process for registering medical device and IVD products.

Medical Device and IVD Registration in China is presented by Janice Ma, Operations Director & Co-founder, of ChinaGate Ltd. For more details on this conference, please visit our site www.fxconferences.com