The hold up in china is due to the changes the CFDA made in 2014 for medical devices entry ( julians response when I asked the question). Its a longer process now. See link below
https://www.ropesgray.com/~/media/Files/alerts/2014/04/20140401_China_LS_Alert.ashx
Definitely on their radar though
It's about Contacts and Names, page-7
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