Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China
2013; Public Library of Science; Volume: 10; Issue: 9 Linguagem: Inglês
10.1371/journal.pmed.1001519
ISSN1549-1676
AutoresDaniel B. Kramer, Yongtian Tina Tan, Chiaki Sato, Aaron S. Kesselheim,
Tópico(s)Healthcare cost, quality, practices
ResumoWe evaluated strategies for postmarket surveillance of medical devices in the United States, European Union, Japan, and China.N Each system shares several common elements, including primary reliance on passive adverse event collection for marketed devices, but vary widely in their allocation of stakeholder responsibilities and mechanisms for evaluating the performance and safety of approved devices.N Postmarket surveillance may be improved through greater system transparen- cy, scheduled re-examination of approved devices, and balancing central and local control.
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