Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China

PLoS Medicine

Volumn 10, Issue 9, 2013, Pages

  Kramer, Daniel B ^a,b   Tan, Yongtian T ^a   Sato, Chiaki ^c   Kesselheim, Aaron S ^a,d  

^a HARVARD MEDICAL SCHOOL   (United States)

^b BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^c UNIVERSITY OF TOKYO   (Japan)

^d BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CHINA; CORONARY STENT; DATA BASE; DEVICE SAFETY; EUROPEAN UNION; EXTERNAL DEFIBRILLATOR; FOOD AND DRUG ADMINISTRATION; HIP PROSTHESIS; JAPAN; LEFT VENTRICULAR ASSIST DEVICE; MEDICAL AUDIT; MEDICAL DEVICE; MEDICAL DEVICE REGULATION; POSTMARKETING SURVEILLANCE; PROFESSIONAL PRACTICE; TRANSCATHETER AORTIC VALVE IMPLANTATION; UNITED STATES;

CHINA; EQUIPMENT AND SUPPLIES; EUROPEAN UNION; JAPAN; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES;

EID: 84884632062     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1001519     Document Type: Article

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