December 6, 2017
On November 14th 2017, Center for Medical Device Evaluation (CMDE) released "The Draft of the Guidance of Accepting the Overseas Clinical Trial Data for Medical Device", which is applicable to medical devices (including in vitro diagnostic reagents, IVDs). CFDA now accepts that the foreign manufacturers could use the overseas clinical trial data during the registration in China. This Guidance is searching for the Public opinion until December 13th 2017.
The overseas clinical trial data shall follow three basic principles: (1) ethical principle, (2) legal principle, and (3) scientific principle. Moreover, the guidance requires that the submission documents from the applicant shall contain at least: The Clinical Trial Program, The Ethics Committee Opinion and The Clinical Trial Report. The clinical trial report shall include the analysis and conclusion of the complete clinical trial data.
The reviewers will consider the relevant factors and technical requirements when checking the overseas clinical trial data, such as “the difference between the technical requirements,” “the difference between the subjects,” and “the difference of the clinical trial conditions.”