IMDRF Undertakes New Clinical Evaluation Project Proposed By China

China’s Food and Drug Administration reported that International Medical Device Regulators Forum (IMDRF) members unanimously supported China’s proposal for a new work item on clinical evaluation of medical devices — presented during the March 20-22 IMDRF meeting in Shanghai.

The proposal calls for international collaborative research on basic requirements for clinical trial decisionmaking, requirements for clinical evaluation and accepting data from overseas clinical trials. It is the first proposed project China has submitted to IMDRF.

Read the CFDA notice here: www.fdanews.com/03-27-18-China.pdf.