Postmarket surveillance of medical devices: a comparison of strategies in the US, EU, Japan, and China.
Harvard Medical School, Boston, Massachusetts, United States of America ; Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.
Daniel B
DB
Kramer
Yongtian T
YT
Tan
Chiaki
C
Sato
Aaron S
AS
Kesselheim
D002681:China; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D007564:Japan; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States