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November 13, 2016, Inside Medical Devices
On October 20, 2016, the Center for Medical Device Evaluation of China Food and Drug Administration (CMDE) released Guidance for the Management of Inquiry on Medical Device Technical Review (“New Guidance”). The New Guidance replaces CMDE’s Guidance for the Management of Technical Inquiry on Registration of Medical Device (effective as of March 26, 2007, the ...
June 8, 2016, Inside Medical Devices
On May 20, 2016, the China Food and Drug Administration (“CFDA”) published drafts of two medical device clinical trial exemption catalogues on Class II and Class III devices for public comment (“CFDA Draft Catalogues”). Comments are due on June 20, 2016. This is the second round of clinical trial exemption catalogues since the revisions to … Continue Reading