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Title:	產業競爭優勢之提升: 以醫療器材產業為例 The Enhancement of industrial competitive advantage: taking the medical equipment industry as an example
Authors:	葉家源 Yeh, Chia-Yu
Contributors:	羅明琇 Lo, Ming-Shiow 葉家源 Yeh, Chia-Yu
Keywords:	產業競爭醫療批號條碼辨識系統 PDA 掃描機 medical equipment marketing regulations single identification system for medical equipment barcode and batch number traceability system PDA scanner
Date:	2020
Issue Date:	2020-09-02 11:57:33 (UTC+8)
Abstract:	醫療器材是一個相當多元化而新興的產業，也是高度複雜而且跨領域整合的產業，其種類相當繁多而且相當廣泛，而且受到世界各國以嚴格的法規限制來做特許經營。然而，近幾年醫療器材已經接近以5%的幅度在成長。若要在此產業之中推廣醫療器材，首先產品要獲得醫療器材的許可認證，之後才會有機會銷售。一旦開始銷售，則必須完全依照法規的要求，開始做上市之後的監督工作，每一項產品必須要有正確的醫療器材單一識別系統(UDI)條碼，和批號來配合追蹤追溯系統，一旦有任何的市場狀況發生，則需要通報全國藥物不良反應通報中心，在必要時，需要做適度的回收工作。醫療器材的銷售通路及商業模式相當傳統化。但是一旦有機會切入市場，其行銷活動就比較不會受到大環境的影響。本研究提出一系列臺灣醫療器材產業，如何因應醫療器材單一識別系統(UDI)條碼追蹤追溯系統的注意事項。同時提出對已經在產業之中的業者，及對政府單位的建議。在研究之中所提出對於未來發展的方向為開發優質而標準化的商品、邁向高門檻及精密化的商業模式，發展多功能系統於一爐、微型化以及利用高科技來發展新的商品。本研究預計給予業者能夠認知到認證的取得並非長治久安及長銷的保證，同時本研究正確地引進醫療器材單一識別系統(UDI)條碼和批號，來配合追蹤追溯系統，培養異業能力的相互整合來創造附加價值。 The Medical equipment is a diversified and emerging industry, as well as a highly complex technology integration industry. Not only that, but its variety is quite large and extensive, and it is subject to strict legal restrictions on franchising in various countries. However, in recent years, the international sales of medical equipment have almost been growing by 5%. Taiwan is also growing with an increase in exports ranging from 3-10%.To promote the medical equipment in this industry, first of all, products must obtain medical equipment license certification, and then only have the opportunity to sell. Once it starts to sell, it must follow the requirements of the regulations to start the post-marketing supervision work. Each product must have the correct medical equipment unique device identification system (UDI) barcode, and batch number tracking system, once there is any market To give back, you need to notify the National Adverse Drug Reaction Notification Center, and when necessary, you need to do a recycling and issue a notice. The sales channel of medical equipment is conservative, not only the channel is quite conservative, but also the developed business model is quite conservative. marketing will be less affected by the environment. This study proposes a series of considerations for how the Taiwan medical device industry is responding to the UDI barcode tracking system during the development process. new entrants and government units who want to enter the industry. In the research, it is proposed that the future development direction is to develop high-quality standardized products, toward a high-threshold precision business model, develop multi-functional systems in one machine, miniaturize, and develop new products using high technology. This research expects to give the practitioners the ability to recognize that the certification is only an admission ticket, not an amulet. At the same time, the medical equipment unique device identification system (UDI) barcode and batch number and the tracking and tracing system are correctly introduced to cultivate the integration of different industries To create added value.
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Description:	碩士國立政治大學經營管理碩士學程(EMBA) 107932403
Source URI:	http://thesis.lib.nccu.edu.tw/record/#G0107932403
Data Type:	thesis
DOI:	10.6814/NCCU202001524
Appears in Collections:	[Executive Master of Business Administration] Theses

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