Your company has decided to expand its product into China. However, the Chinese regulatory landscape for medical devices has been undergoing frequent changes. Within the past 12 months, the Chinese Food and Drug Administration (CFDA) has been moved back to a ministry level position, issued new regulations on how re-registration is performed, created requirements for supplier/distributor practices, and many other changes. In addition, on February 12th of 2014, the State Council approved the new medical device regulations that have been in draft form since 2008.
What does this mean for your product expansion into the China Medical Device Market? What hurdles will you face? Not just with regulations, but clinical trials.
The Biocompatibility and Performance of Medical Devices Symposium (BPMDS) is the event to attend to answer the many questions you may have on these topics. Not only will you learn about the regulations in China from the experts, but you will have a chance to meet with them throughout the seminar.
This seminar has experts from both China and Europe with experience in the different areas of the China Medical Device Market. Our latest updates can be found in our news section.