China Med Device cordially invites you to our latest regulatory event in Boston on December 10th, 2017 and the opportunity to meet face to face with two prominent China FDA reviewers and decision-makers. Our CFDA keynote speakers, Bin Liu and Yue Bin will address the latest CFDA updates and common pitfalls and answer your questions. Organizer and CMD CEO, Grace Fu Palma will moderate the evening’s program.
China Med Device, LLC (www.ChinaMedDevice.com) in collaboration with the Chinese-American BioMedical Association (CABA) brings you this live event with two knowledgeable delegates directly from the CFDA Center for Medical Device Evaluation (CMDE) in Beijing to share best practices and help US medtech companies gain better understanding of the CFDA premarket approval process and policy changes.
Attendees will have the opportunity to:
- Listen to the latest CFDA premarket approval changes and updates impacting medical devices premarket approval, clinical evaluation and clinical trials.
- Learn how to avoid common pitfalls in the CFDA premarket submission process (technical, clinical and documents).
- Share US medtech companies’ regulatory approval experiences and learnings.
- Bridge the communication gap and understand the differences between US FDA and China FDA.
Bin Liu, Director, Center for Medical Device Evaluation, CFDA
A biological materials research professor, 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 reviews, 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, Center for Medical Device Evaluation, CFDA
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 guidelines, such as “Guidelines for the Review of Hip Prostheses”. She contributed to the studies on the regulation 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). Yue MIN has a Master of Biomedical Engineering.
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