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Jiao Hong Attendes the Open Meeting of the 13th International Medical Device Regulators Forum(IMDRF)
2018-03-23

On the afternoon of March 21,2018,Jiao Hong,Vice Minister of China Food and Drug Administration (CFDA),attended the Open Meeting of the 13th IMDRF and delivered a speech.
Jiao Hong pointed out that IMDRF's vision is to achieve the coordination of international medical device regulatory by consensus,China endorses and supports to achieve this goal.The rapid development of medical device innovation in the world has become an important force to lead the transformation of medical model and advance the progress of medical diagnosis and treatment.With the implementation and revision of Chinese 2014 edition of “the Regulations on Supervision and Administration of Medical Devices”,and a series of related regulations promulgated and implemented,we are through increasing reform,review and approval system to strengthen the review team ability construction,launch measures encourage innovation of medical devices,further release of industry vitality,promote industrial innovation and development.As a full member of IMDRF,we put forward proposals for new work projects at this conference,and introduced China's good experience and practices,and strengthened communication with regulators.As the rotating presidency of IMDRF 2018,we will conscientiously carry out the responsibilities of the president in accordance with the statutes and procedures of the IMDRF,and promote the implementation of the working group project as planned. We will also pay attention to the opinion of the industry,and try to find a global solution on the IMDRF platform for the hot and difficult problems of medical device regulatory.
IMDRF's opening session was hosted by the CFDA.In this open meeting,10 official members of the IMDRF Management Committee introduced the progress of national medical device regulations respectively.The 7 working groups currently being carried out in IMDRF are in turn introducing the progress and results of the work.The conference also organized a symposium on"artificial intelligence medical devices".Finally,representatives of three Chinese and foreign trade associations (CAMDI,DITTA and GMTA); IMDRF official observer(WHO),official invited observer's Saudi Arabia FDA;three regional coordinating organization (APEC LSIF-RHSC,AHWP and PAHO) respectively reported on the work of relevant medical devices.

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