A blog about what is new (and old) in the world of active implantable medical devices 

Facebook Twitter Gplus Flickr LinkedIn YouTube RSS
magnify
Home AIMD Business Submitting AIMD System Applications to China’s State FDA
formats

Submitting AIMD System Applications to China’s State FDA

Beijing Institute of Medical Device Testing David Prutchi Ph.D. www.implantable-devices.com

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.

Beijing Institute of Medical Device Testing David Prutchi Ph.D. www.implantable-devices.com

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!

BIMT EMC Chambers David Prutchi PhD

 PS.  My photos of Beijing are at: http://www.flickr.com/photos/prutchi/sets/72157640189751133/

 

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off on Submitting AIMD System Applications to China’s State FDA  comments