Workshop 1: US vs. China – Regulation, Standard, and Innovation – II:
Session Co-Chairs: Andy Doraiswamy, PhD, Arthur Coury, PhD, Xingdong Zhang, PhD, Wei
Lui, MD, PhD
Invited Speakers: Wei Sun, PhD, Carl Simon, PhD, Hong Lin, Michael Yazemski, MD, PhD,
Yiwu Zhao, James M. Anderson, MD, PhD, Yunbing Wang, PhD, Casey Hughes
The workshop is a continuation to the series that began in SFB 2013 to promote
discussions between innovation, testing, standards, and regulation for medical devices
and biomaterials between US and China. The session will encompass presentations
on the topic of regulation, standards, and innovations between the two nations by
opinion leaders from academia, regulatory bodies, and industry. The workshop will
serve as a forum for discussions in developing a medical device from conception to
commercialization between the two countries.

美方：James M. Anderson介绍了ISO10993，Carl Simon介绍了美国的NIST，Michael Yazemski介绍了 FDA的一些情况，Casey Hughes缺席开了天窗。

中方：孙伟老师介绍了Bio 3-D print，林红老师介绍了口腔材料的评价法规和标准，林英创老师介绍了纳通的可降解材料，王云兵老师介绍了革新性医疗器械研发。