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The International Clinical Evaluation Harmonisation Project for International Medical Devices Initiated by China is Approved Unanimously
2018-03-23

On March 20,2018 to March 22,the management committee meeting of 13th International Medical Device Regulators Forum (IMDRF) undertaken by China as the rotating president held in Shanghai,the United States,the European Union,Japan and other 10 countries and regions regulators as full members of the management committee,attended the meeting, the World Health Organization (WHO) as an official observer attended the meeting. At the meeting,the new work item of "Clinical Evaluation of Medical Devices" proposed by China was unanimously supported by the participating members.
In recent years,China's medical device regulatory work and the international medical device regulatory have developed together.On the basis of in-depth investigation and argumentation,and soliciting opinions from the members,at this meeting,China formally submitted to IMDRF management committee the proposal of "Clinical Evaluation of Medical Devices" new work project,and successfully established the project.The project is committed to conducting international collaborative research on the basic requirements of clinical trial decision making,the basic requirements for clinical evaluation through isotropic reasoning and the acceptance of data from overseas clinical trials.
"Clinical Evaluation of Medical Devices" project is the first time since our country joined IMDRF as project sponsor to the new work item proposal is put forward,it marks the after years of effort medical device regulatory in our country has gradually realized from the participants to the leading role transformation,IMDRF through this platform,to explore the experience accumulated over the years to be shared with IMDRF members,find solutions under IMDRF mechanism,harmonious and unified requirement for clinical evaluation of different members,further advancing the global medical device clinical evaluation of scientific,rationalization,standardization,for medical device regulatory agencies and make positive contributions to the industry stakeholders in the international arena to show China’s good image of a responsible big country.

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