I just came back from Beijing where we are in the process of registering our AIMD systems. The process if very different than submitting an application to a EU Notified Body or to FDA. This is because China’s State FDA (S-FDA) doesn’t accept testing performed abroad. S-FDA only accepts testing performed at one of the Chinese nationally-recognized test labs, so it doesn’t matter how or who did your testing outside of China, your devices must be retested by one of the Chinese NRTLs to applicable standards.
We are performing our testing at the Beijing Institute of Medical Devices (BIMT) – a World-Class testing laboratory equipped with the very latest test equipment (including beautiful, new 10m and 30m EMC chambers brought from France, and equipped with top-of-the-line equipment by Rohde&Schwarz, Tektronix, Agilent, etc.). Most importantly, I found their engineers to be very knowledgeable and kind. It was a really pleasant experience!
PS. My photos of Beijing are at: http://www.flickr.com/photos/prutchi/sets/72157640189751133/