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    Please use this identifier to cite or link to this item: http://tkuir.lib.tku.edu.tw:8080/dspace/handle/987654321/105328

    Title: 醫療器材輸入風險之研究
    Other Titles: A study of the risk in importing medical devices
    Authors: 陳華清;Chen, Hua-Ching
    Contributors: 淡江大學管理科學學系企業經營碩士在職專班
    Keywords: 全民健保;總額預算制度;輸入查驗登記;特殊材料;風險;national health insurance;Global Budget Payment System;Regulations for Registration of Medical Devices;Special Materials;Risks
    Date: 2015
    Issue Date: 2016-01-22 14:53:20 (UTC+8)
    Abstract: 本研究主要探討醫材進口販售,國內相關進口法規,包括製造廠品質系統文件,輸入查驗登記制度,全民健保特殊材料收載核價;總額預算制度醫院採購行為、及設備商與同業競爭等問題分析,探討目前國內輸入醫材所可能面臨之相關風險。
    The study mainly investigates the risks involved in importing medical devices for selling on QSD (Quality System Document), including regulations for registration of medical devices, the reimbursement of the medical special materials for health insurance, and the procurement behaviors of the hospitals implementing the global budget payment system.
    The study indicates that some sections of the regulations for importing medical device are still un-clear, un-harmonized enough with the global practices, the certified procedures are tedious, the enterprises could face the possibility not to be permitted when applying for the certificate extension and renewal. The global budget payment system had influenced the buying behavior of hospitals to purchase the medical devices with an unreasonable low price, it would make cutting-price as the major competitive strategy in the market. It would also influence the price of accessories.
    The suggestion of the study focus on both dimensions of regulations and products, For regulations, it includes 1. Simplify the application procedures for importing medical devices. 2. Harmonize with global regulations, 3. Reimburse health care special materials 4. Establish deductibles on some materials. For products, it includes 1. Cut down the selling price. 2. Innovate product. 3, Implement product differentiation strategy.
    Appears in Collections:[管理科學學系暨研究所] 學位論文

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