Medical device registration system comparison between China and U.S.A
Yue, W.
Zhongguo Yi Liao Qi Xie Za Zhi 33(1): 51-58
2009
ISSN/ISBN: 1671-7104 PMID: 19459353 Document Number: 631868
The paper compares the medical device registration system between China and FDA in U.S.A., with the main focus on the problems of design default of supervision and management in Chinese system. It analyzes the primary elements of substantial equivalence approval in medical device registration, and points out the design defaults of our medical device registration system and the basic points which need to be handled.