Many thanks to Aaron Lu of the University of Virginia for bringing two important updates to our attention regarding medical device regulation in China:

(1) In 4.2  Regulatory Basics, we say that a device must receive marketing approval in its country of origin before it can be registered in China. However, Chinese regulatory authorities now allow the registration of foreign medical devices that do not have approval from the country of origin. Read more here for Class I devices, or here for Class II and III technologies.

(2) Also in chapter 4.2, we state that certain devices must obtain a CCC mark before being sold in China. Prior to 2013, eight categories of medical devices were subject to this requirement. However, the Chinese FDA recently created exemptions that effectively eliminated the need for a CCC mark for any medical device in China. More information can be found here.