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題名:植入性醫材登錄監視制度與病人權益保障
書刊名:臺灣公共衛生雜誌
作者:陳再晉鐘珮純陳冠文蕭允強
作者(外文):Chen, Tzay-jinnChung, Pei-chunnChen, Kuan-wenHsiao, Yun-chiang
出版日期:2020
卷期:39:3
頁次:頁235-239
主題關鍵詞:植入性醫療器材監視制度病人權益醫療器材管理法
原始連結:連回原系統網址new window
相關次數:
  • 被引用次數被引用次數:期刊(1) 博士論文(0) 專書(0) 專書論文(0)
  • 排除自我引用排除自我引用:1
  • 共同引用共同引用:0
  • 點閱點閱:1
期刊論文
1.Lenzer, J.(2018)。Medical device industry: international investigation exposes lax regulation。BMJ,363。  new window
2.黃淑英、陳書芳(20190600)。醫療植入物的現況與管理--從乳房植入物談起。月旦醫事法報告,32,31-42。new window  延伸查詢new window
其他
1.陳偉婷(20191007)。未取得認證就出貨逾7.4萬違法骨釘骨板入市面,https://www.cna.com.tw/news/firstnews/201910070084.aspx。  延伸查詢new window
2.International Consortium of Investigative Journalists。Implant files,https://www.icij.org/investigations/implant-files/。  new window
3.黃淑英。高風險醫療植入物應有「使用者登錄制度」,https://talk.ltn.com.tw/article/paper/1324623。  延伸查詢new window
4.U.S. Food and Drug Administration。Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL),https://wayback.archive-it.org/7993/20180908081629/https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm, 。  new window
5.US FDA。PMA approvals,https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/pma-approvals, 。  new window
6.U.S. FDA。Medical device overview,https://www.fda.gov/industry/regulated-products/medical-device-overview。  new window
7.IMARC Research。'The bleeding edge' raises big questions for medical device manufacturers,https://www.imarcresearch.com/blog/medical-device-manufacturers-bleeding-edge-。  new window
8.U.S. FDA。Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA's 510(k) program to advance the review of the safety and effectiveness of medical devices,https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-jeff-shuren-md-director-center-devices-and。  new window
9.U.S. FDA。Harnessing real world evidence for safety and innovation,https://www.fda.gov/news-events/speeches-fda-officials/haraessing-real-world-evidence-safety-and-innovation-11192018。  new window
10.衛生福利部(20191213)。立法院三讀通過醫療器材管理法草案,醫療器材產業邁入新紀元,https://www.mohw.gov.tw/cp-16-50552-1.html。  延伸查詢new window
11.臺北醫學大學衛生福利政策研究中心。108.11.26 [植入性醫療器材登錄監視制度之建構]會議紀實。  延伸查詢new window
12.監察院。監察院108內調0032人權調查報告,https://humanrights.cy.gov.tw/CyBsBoxContent.aspx?n=340&s=6518。  延伸查詢new window
 
 
 
 
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