Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation.
Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, Japan, and China to device regulation with a focus on postmarket surveillance. These markets share broad features such as a heavy reliance on passive adverse event collection, reflected by growing enthusiasm for more active and dynamic mechanisms such as unique device identification. More immediately, US and EU systems might benefit from scheduled, compulsory, and consequential re-examination of select devices, as is done in Japan and China, in order to strengthen post-market protection of patients and bolster public health.
Daniel B
DB
Kramer
Yongtian T
YT
Tan
Chiaki
C
Sato
Aron S
AS
Kesselheim
D002681:China; D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety; D005062:European Union; D033161:Government Regulation; D006801:Humans; D007564:Japan; D062307:Medical Device Legislation; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration