The 4th Chinese Medical Devices Risk Management Forum Held

  • 2017-04-28

On April 25-26, China Food and Drug Administration (CFDA) Center for Drug Reevaluation (CDR) (the National Center for Adverse Drug Reaction Monitoring) and CAMDI held the “4th Chinese Medical Devices Risk Management Forum” in Suzhou, Jiangsu. Sun Lei, the deputy director of CFDA Medical Device Supervision Department, Yang Wei, the director of CFDA Center for Drug Reevaluation, Yu Shanjun, the deputy director of JSFDA Center for Drug Reevaluation and Zhao Yixin, the chairman of CAMDI, and other leaders made speeches for the conference. Nearly thousands of representatives from medical institutions, manufacturers and regulatory authorities attended the forum.

This forum was themed at “Innovation and Progress of Medical Devices Risk Management”, and nearly 40 domestic and overseas experts and scholars made keynote speeches on the latest research progress in their respective fields. Prof. Dai Kerong, the academician of Chinese Academy of Engineering made a keynote speech on “Role and Responsibility of the R&D and Application Staff in Medical Device Risk Management”. Zhu Ning, the Chief of CFDA Medical Device Supervision Department Monitoring & Evaluation Division made a keynote speech on “Post-marketed Medical Device Supervision”. Mr. Bill Sutton, the assistant director of FDA’s office in China made a keynote speech on “The Strategy of FDA for Balancing Risk of Post-market Medical Device”.

There were three branch venues for this forum, including “application of medical device products and failure risk analysis”, “design of medical device products” and “medical device administration and risk evaluation”. The innovation and progress of medical devices risk management were discussed from the perspectives of medical institutions, manufacturers and regulatory authorities. As agreed by all the participants, the forum was rich and fresh in content, creating a good platform for communication between medical institutions, manufacturers and regulatory authorities and facilitating the improvement of Chinese medical device risk management level. 


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