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活动详情

Meet CFDA Representatives from Center for Medical Device Evaluation at Cambridge Innovation center (1 Boradway, 5th Floor, Cambridge, MA 02142), Sunday, December 10, 2017, 4:00pm - 6:00pm.

NOTE: Number of Attendees is limited. Dinner will follow the meeting.

 

2017 CABA  Medical Device Regulatory Expert Forum is co-organized with China US Boston Innovation Center (CUBIC), sponsored by China Med Device, LLC.

Program Description:

Face to Face Discussion with China FDA Representatives from Center for Medical Device Evaluation

 

CABA brings you the live event with the delegate directly from CFDA Center for Medical Device Evaluation (CMDE) in Beijing to share best practice and help US medtech companies gain better understanding of CFDA premarket approval process and changes.

  • Listen to the latest CFDA premarket approval changes and updates impacting medical devices premarket approval, clinical evaluation and clinical trials.
  • Avoid common pitfalls in CFDA premarket submission process (technical, clinical and documents).
  • Share US medtech companies’ regulatory approval experience and learning.
  • Bridge the communication and understanding of the differences between US FDA and China FDA.

 

Come & meet face to face with CFDA pre-market evaluation team members from Beijing. Ask questions. Contribute your insights during the audience interactive segment. Discover what you need to know to avoid pitfalls and stay on top your approval process.


Expert Speakers:

Bin Liu, Director of Division IV, Center for Medical Device Evaluation, CFDA

Bin LIU, a biological materials research professor, is director of Division IV, Center for Medical Device Evaluation (CMDE), China Food and Drug Administration (CFDA), and a member of the State Ministry of Science and Technology’s “Additive Manufacturing and Laser Manufacturing” focused special group of experts.
Mr. Liu holds the positions of deputy director of the Committee for Bone Repair and Devices Branch of China Biological Materials Institute (CBMI), deputy director of the Committee for Advanced Manufacturing Branch of CBMI, and a member of the Sub-committee of Orthopedic Implants in the National Surgical Implants Standards Technical Committee. He engaged in orthopedic clinical research and orthopedic implants technical review each for more than 10 years, led the technology research for registration management policy theory for custom medical devices, and participated as a major contributor in drafting multiple national and industry standards for the National Surgical Implants and Orthopedic Devices Standardization Technical Committee.

Yue Min, Reviewer, Division IV, Center for Medical Device Evaluation, CFDA

Yue MIN, master of biomedical engineering, is a reviewer for the technical review of orthopedic implants and surgical devices at Division IV, Center for Medical Device Evaluation (CMDE), China Food and Drug Administration (CFDA). Yue participated in the preparation of multiple guiding principles, such as the Guiding Principles for the Review of Hip Prostheses, contributed to the studies on the regulation mode for custom medical devices and prepared research reports. She is a member of the Regulated Product Submission (RPS) working group of the International Medical Device Regulators Forum (IMDRF)




Moderators:

Bo Ying, Ph.D. President-Elect, CABA

Grace Fu Palma, CEO, China Med Device, LLC


活动主办方:

Chinese-American BioMedical Association

查看此主办方的其它活动

时间

2017-12-10 16:00 - 开始

2017-12-10 18:00 - 结束

已结束
地点
  • 1 Boradway, 5th Floor, Cambridge, MA 02142 , CAMBRIDGE  MA