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 |
2. | International Consortium of Investigative Journalists。Implant files,https://www.icij.org/investigations/implant-files/。 |
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 |
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, 。 |
5. | US FDA。PMA approvals,https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/pma-approvals, 。 |
6. | U.S. FDA。Medical device overview,https://www.fda.gov/industry/regulated-products/medical-device-overview。 |
7. | IMARC Research。'The bleeding edge' raises big questions for medical device manufacturers,https://www.imarcresearch.com/blog/medical-device-manufacturers-bleeding-edge-。 |
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。 |
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。 |
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 |
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 |
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 |