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中文部分
書籍 1. 李明軒、邱如美 (譯) (1996a)。國家競爭優勢(上) (原作者:Porter, M. E.)。台北市:天下文化。(原著出版年:1989) 2. 李明軒、邱如美 (譯) (1996b)。國家競爭優勢(下) (原作者:Porter, M. E.)。台北市:天下文化。(原著出版年:1989) 3. 施振榮,(1992)。再造宏碁:開創、成長與挑戰。台北市:天下文化。 4. 鄧聚龍,(1999)。灰色系統理論與應用。新北市:高立圖書有限公司.
期刊 5. 工研院IEK醫療器材與健康照護研究部 (2013)。全球醫療器材產業之動態與未來發展。證交資料,617,44-56。 6. 汪嘉林 (2011)。我國生技製藥產業-創新演化的回顧與前瞻。科學發展,457,146-150。 7. 吳宜靜 (2017)。各國官方醫療器材諮詢輔導制度簡介與比較。當代醫藥法規月刊,76,11-22。 8. 黃齡慧 (2014)。兩岸醫藥品後市場不良品或不良反應事件處理機制及流程之比較。當代醫藥法規,47,13-23。
網際網路 9. Leadership (2017)。醫療器材單一稽核計畫Medical Device Single Audit Program, MDSAP。取自 https://www.isoleader.com.tw/home/iso-coaching-detail/MDSAP 10. 灰色關聯分析 (GRA)的理論及應用 (matlab和python) (2018)。CSDN。 取自https://blog.csdn.net/starter_____/article/details/82085040 11. 一O四人力銀行 (2019a)。2019年薪資情報,2019年薪資情報>醫療/保健服務人員>醫療設備控制人員。取自https://www.104.com.tw/jb/wage/list?type=1&jobcat=2015002000&cat=jobother 12. 一O四人力銀行 (2019b)。2019年薪資情報,2019年薪資情報>生技/醫療研發類人員>醫療器材研發工程師。取自 https://www.104.com.tw/jb/wage/list?type=1&jobcat=2008003000&cat=jobmake 13. 行政院 (2017)。行政院會通過「醫療器材管理法」草案。焦點新聞。取自 https://www.mohw.gov.tw/cp-16-38880-1.html 14. 行政院新聞傳播處 (2016)。推動臺灣生醫產業發展—打造臺灣成為亞太生醫研發產業重鎮。行政院全球資訊網。取自 https://www.ey.gov.tw/hot_topic.aspx?n=1790530619D64B88&sms=3D3EC61B5354AFE2. 15. 科技會報辦公室 (2012)。臺灣生技產業起飛行動方案。取自https://ws.ndc.gov.tw/Download.ashx?u=LzAwMS9hZG1pbmlzdHJhdG9yLzEwL3JlbGZpbGUvNjA5NS8xMTcxMS8wMDEyNDQ1XzEyLnBkZg%3D%3D&n=55Sf5oqA6ZG955%2Bz6LW36aOb6KGM5YuV5pa55qGIICDooYzli5XoqIjnlasucGRm&icon=..pdf 16. 科技會報辦公室 (2016)。全力推動生醫產業創新方案 打造台灣成為研發產業重鎮 發展生技產業成為兆元產業。取自 https://www.ey.gov.tw/Page/448DE008087A1971/b1f16e16-f3eb-488d-ada7-a9c289d444cc 17. 財政部關務署 (2018)。97-106年 進出口貨物價值排行統計 - 總值 按貨品別。取自 https://portal.sw.nat.gov.tw/APGA/GA01 18. 財團法人醫藥工業技術發展中心 (2016)。醫療器材臨床試驗豁免(IDE)利益風險決議考量因素。取自https://www.mdic.org.tw/Law_detail/5904 19. 國家發展委員會 (2017)。協調推動產業創新計畫。取自 https://www.ndc.gov.tw/Content_list.aspx?n=9D024A4424DC36B9&upn=6E972F5C30BF198F. 20. 國家實驗研究院 (2014)。國研醫材創價聯盟啟動 引領台灣直衝兆元產值。取自 https://www.narlabs.org.tw/xmdoc/cont?xsmsid=0I148622737263495777&sid=0I163377989760838255 21. 產經觀測站 (2018)。醫療新南向 要組國家隊。取自 http://www.srido.org.tw/newsouthboundpolicy/201 22. 經濟部工業局 (2017)。2017生技產業白皮書。取自https://www.moeaidb.gov.tw/ctlr?PRO=publication.rwdPublicationView&id=3382 23. 經濟部統計處 (2019)。工業產銷存動態調查-業別統計。取自 https://dmz26.moea.gov.tw/GMWeb/investigate/InvestigateDB.aspx 24. 葉席吟 (2015)。醫療器材產業之產學鏈結探討。科技政策觀點。取自 https://portal.stpi.narl.org.tw/index/article/10097 25. 葉席吟 (2016)。精準醫療之各國推動政策觀察。科技政策觀點。取自https://portal.stpi.narl.org.tw/index/article/10278;jsessionid=A99B47720ACB77FD1D21611B6DEC6612 26. 人體試驗管理辦法 (2016)。衛生福利部。取自https://law.moj.gov.tw/LawClass/LawAll.aspx?PCode=L0020162 27. 醫療法 (2018)。衛生福利部。取自https://law.moj.gov.tw/LawClass/LawAll.aspx?PCode=L0020021 28. 衛生福利部 (2019)。醫療保健支出占GDP之比率。取自 https://www.gender.ey.gov.tw/gecdb/Stat_Statistics_DetailData.aspx?sn=jtg6KRQTviFsfOzy4n38lQ%3D%3D&d=194q2o4%2BotzoYO%2B8OAMYew%3D%3D 29. 衛生福利部食品藥物管理署 (2016)。醫療器材分類分級查詢資料庫。取自 http://mdlicense.itri.org.tw/MDDB/Classification/Classification.aspx 30. 衛生福利部統計處 (2018)。106年死因統計結果分析。取自https://dep.mohw.gov.tw/DOS/cp-3960-41756-113.html 31. 衛生福利部食藥署 (2013)。衛生福利部食品藥物管理署申請案件處理期限表。取自https://www.fda.gov.tw/TC/siteContent.aspx?sid=2953 32. 顏嘉妤 (2016)。國內醫療器材臨床試驗申請法規介紹。取自 http://www.cde.org.tw/ReadFile/?p=News&n=f398d826-2da7-44c9-8887-10afb4dc276b.pdf
英文部分
書籍 1. Porter, M. E. (1990). The Competitive Advantage of Nations. In (pp. 247-252): New York: Free Press.
期刊 2. Bloland, P., Simone, P., Burkholder, B., Slutsker, L., & De Cock, K. M. (2012). The Role of Public Health Institutions in Global Health System Strengthening Efforts: The US CDC's Perspective. PLOS Medicine, 9(4), e1001199. doi:10.1371/journal.pmed.1001199 3. Dickler, H. B., Korn, D., & Gabbe, S. G. (2006). Promoting Translational and Clinical Science: The Critical Role of Medical Schools and Teaching Hospitals. PLOS Medicine, 3(9), e378. doi:10.1371/journal.pmed.0030378 4. Fleminger, J., & Goldacre, B. (2018). Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register. PLOS ONE, 13(3), e0193088. doi:10.1371/journal.pone.0193088 5. Geremia, F. (2018). Quality aspects for medical devices, quality system and certification process. Microchemical Journal, 136, 300-306. doi:10.1016/j.microc.2017.04.018 6. Hines, J. Z., Lurie, P., Yu, E., & Wolfe, S. (2010). Left to their own devices: breakdowns in United States medical device premarket review. PLOS Medicine, 7(7), e1000280-e1000280. doi:10.1371/journal.pmed.1000280 7. Kramer, D. B., Baker, M., Ransford, B., Molina-Markham, A., Stewart, Q., Fu, K., & Reynolds, M. R. (2012). Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance. PLOS ONE, 7(7), e40200. doi:10.1371/journal.pone.0040200 8. Kramer, D. B., Xu, S., & Kesselheim, A. S. (2012). How does medical device regulation perform in the United States and the European union? A systematic review. PLOS Medicine, 9(7), e1001276-e1001276. doi:10.1371/journal.pmed.1001276 9. Li, T.-W., Tu, P.-W., Liu, L.-L., & Wu, S.-I. (2015). Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan. BioMed research international, 2015, 670420-670420. doi:10.1155/2015/670420 10. O'Connor, B., Pollner, F., & Fugh-Berman, A. (2016). Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives. PLOS ONE, 11(8), e0158510-e0158510. doi:10.1371/journal.pone.0158510 11. Rising, J. P., & Moscovitch, B. (2015). Characteristics of Pivotal Trials and FDA Review of Innovative Devices. PLOS ONE, 10(2), e0117235. doi:10.1371/journal.pone.0117235 12. Roberto, A., Radrezza, S., & Mosconi, P. (2018). Transparency in ovarian cancer clinical trial results: ClinicalTrials.gov versus PubMed, Embase and Google scholar. Journal of ovarian research, 11(1), 28-28. doi:10.1186/s13048-018-0404-1 13. Ross, J. S., Blount, K. L., Ritchie, J. D., Hodshon, B., & Krumholz, H. M. (2015). Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey. Medical devices (Auckland, N.Z.), 8, 241-249. doi:10.2147/MDER.S82964 14. Sorenson, C., & Drummond, M. (2014). Improving medical device regulation: the United States and Europe in perspective. The Milbank quarterly, 92(1), 114-150. doi:10.1111/1468-0009.12043 15. Stern, A. D. (2017). Innovation under Regulatory Uncertainty: Evidence from Medical Technology. Journal of public economics, 145, 181-200. doi:10.1016/j.jpubeco.2016.11.010
網際網路 16. export.gov. (2018). Taiwan - Medical Devices. Taiwan Country Commercial Guide. Retrieved from https://www.export.gov/article?id=Taiwan-Medical-Devices 17. FDA. FD&C Act Chapter V: Drugs and Devices. Federal Food, Drug, and Cosmetic Act (FD&C Act). Retrieved from https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/federalfooddrugandcosmeticactfdcact/fdcactchaptervdrugsanddevices/default.htm 18. FDA. (2017). Digital Health Innovation Action Plan. Retrieved from https://www.fda.gov/media/106331/download. 19. FDA. (2018). What is a Medical Device Recall? Medical Device Recalls. Retrieved from https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm329946.htm 20. Fortune. (2018). Fortune 500. Retrieved from http://fortune.com/fortune500/ 21. OECD. (2019). Health spending. Retrieved from https://data.oecd.org/healthres/health-spending.htm 22. Tippmann, N. (2018). Medical Device Companies - Top 100 In 2018. Retrieved from https://www.greenlight.guru/blog/top-100-medical-device-companies
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