On October 31, 2017, the Chinese Regulatory Authority, CFDA, updated the list of Medical Devices exempt from on-site testing.
Through Notification No. 170, additional Class II and III devices and in vitro diagnostic devices were included in the previously published list, making Chinese market access requirements less stringent.
The Authority criteria for approving overseas clinical investigations data were published on November 14, 2017, through the issuance of the “Accepting Medical Devices overseas clinical trial data technical guidelines” currently under public consultation until December 13, 2017.
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