Aaron Gu

Aaron Gu

Subscribe to all posts by Aaron Gu

CNDA Releases New Rules on the Inspection of Medical Device Clinical Trials for Comment

Last month, the China Nation Drug Administration (CNDA, formerly known as China Food and Drug Administration or CFDA), released a draft rule on Inspection Key Points and Guiding Principles of Medical Device Clinical Trials (“New Draft”). This is the third draft rule related to medical device clinical trial inspections that CNDA has issued in the … Continue Reading

CFDA Releases New Administrative Measures on Medical Device Recalls for Comment

The China Food and Drug Administration (CFDA) is expanding its reach over device recalls. In early September, CFDA released a long-awaited draft of the Administrative Measures on Medical Device Recalls (Proposed Rules).  These significantly-expanded measures would replace the current medical device recall rules that the Ministry of Health (now the National  Health and Family Planning … Continue Reading
LexBlog