The CFDA announced the Technical Guidelines on the Acceptance of Data Derived from Overseas Clinical Trials of Medical Devices (“Guidelines”) on the 10 January 2018. The Guidelines apply when applicants use overseas clinical trial data for the registration of medical devices or in-vitro diagnostic reagents. Applicants should clarify the ethical standards that they followed and prove that their trials essentially conform to China’s Good Clinical Practice for Medical Device Trials. They must ensure that their overseas data is complete, reliable and true. During the technical review, the authority will comprehensively evaluate the validity of the trial and take account of the differences between the research subjects and Chinese subjects.