Representatives of China’s SFDA were on hand at the 2011 RAPS Annual Conference to provide an update on regulatory developments in that country. However, what the delegations didn’t say in response to an audience question, was perhaps most interesting.
“On the one hand, SFDA has extensive requirements for product testing and technical file review. On the other hand, there are state-sponsored programs, such as the so-called ’863 Program’ that are devoted to the acquisition of certain high-tech IP for the benefit of the domestic Chinese industry. Can you briefly describe the firewalls that exist between SFDA and the other state agencies to protect medical device IP?”
After a long, pregnant pause, the delegation merely referred to the Chinese office for intellectual property rights – saying that SFDA had no hand in addressing device IP. Of course, this is ridiculous – SFDA is in the busines of accumulating a vast amount of information for every device that enters the country. They are the conduit for US IP and their silence on the safeguards for that IP speaks volumes.
See my previous posts on Chinese Super-Competitors and IP theft.