The Statistics of Imported Class I Medical Device filing in China

China has modified its approval procedure for class I medical device in accordance with the revised regulations (State Decree No. 650), the foreign manufacture are only required to record its class I medical device in China Food and Drug Administration (CFDA) and the record keeping will have its effectiveness permanently and without need for the renew.
Note: How to file the class I medical devices in China can be found here.
CFDA has approved 2492 imported class I medical device in 2016, 465 updates included.

The list of Imported Class I Medical Devices in China can be downloaded List of Imported Class I Medical Device in China (2016-2017)