醫療器材輸入風險之研究

A Study of the Risk in Importing Medical Devices

陳華清(Hua-Ching Chen)

指導教授 ： 李培齊

淡江大學/商管學院/管理科學學系企業經營碩士在職專班/碩士(2015年)

https://doi.org/10.6846/TKU.2015.00570

摘要

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。
研究認為進口法規仍不夠嚴謹，不夠與國際調和，核審程序繁瑣，企業可能會面對許可執照更新或展延不核准情形；健保特材核價收載，價格偏低，將影響高單價產品進口誘因，另外總額預算制度醫院採購方式，趨向低價化，致同業削價競爭，影響設備附件售價。
建議在法規面及產品面的作法：在法規面：1、簡化進口申請程序，2、與國際調和，3、健保差額給付，4、建立部分自費；在產品面：1、降低產品售價，2、產品創新，3、產品差異化行銷。

關鍵字

全民健保 ； 總額預算制度 ； 輸入查驗登記 ； 特殊材料 ； 風險

並列摘要

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.

並列關鍵字

National Health Insurance ； Global Budget Payment System ； Regulations for Registration of Medical Devices ； Special Materials ； Risks:

參考文獻

鄭守夏、陳啟楨 (2014)，｢健保制度下的醫療體制」，台灣醫學Formosan J Med，2014;18:74-84。

楊裕熙 (2007)，ISO 13485: 2003 醫療器材品質管理系統之探討，品質月刊, 43(11), 72-78.。

蘇明綢（2011），醫療器材風險管理與評估初步研究，中原大學醫學工程研究所碩士論文。

林綺莉 (2010)，如何確保醫療器材品質：國際制度比較與我國制度現況分析，臺灣大學健康政策與管理研究所碩士論文。

汪萱蕙 (2014)，台灣經濟研究院產經資料庫統計資料 (醫療保健服務業景氣動態報告)。