台灣中小企業投入醫療器材市場之法規限制與策略研究

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題名:	台灣中小企業投入醫療器材市場之法規限制與策略研究
作者:	徐紹容;Hsu, Shao-Jung
貢獻者:	工業管理研究所
關鍵詞:	法規限制;醫療器材;經營策略;台灣醫療器材產業;Regulatory restrictions;medical equipment;Business strategy;Taiwan medical equipment industry
日期:	2017-06-19
上傳時間:	2017-10-27 12:26:31 (UTC+8)
出版者:	國立中央大學
摘要:	隨著人口老化、各種慢性病人口都逐漸增加，各國都開始致力於醫療產業的發展，其中對於醫療器材的需求也持續增加中。隨著醫療器材產業的蓬勃發展，相關的問題也正在產生中，醫療器材產業的產品種類非常多樣化，且技術領域範圍廣泛的特殊型態產業，產品上市前會牽涉到很多非常嚴謹的法規限制；而各種的法規條件限制，也使得台灣廠商進入醫療器材市場的障礙提高。本研究以目前台灣中小型的醫療器材廠商為主要評估對象，透過評估醫療器材產業的優勢與劣勢，針對不同的法規限制和各國法規趨勢，讓台灣中小企業藉由經營策略改變的方式，於產品設計開發階段，提早加入法規限制的條件，使整體生產流程更加順利，可以毫無障礙的打入醫療器材市場的要求門檻。文中也分析不同的製造商條件與法規條件的差異，進而發展出不同的經營策略，並針對台灣中小型的醫療器材廠商的轉型加以評估。因為醫療器材產業較不受景氣循環的影響，目前台灣多數電子業廠商積極投入醫療器材產業，建議應該要評估兩者法規要求的差異性，儘量降低兩者的差異化，避免造成台灣醫療器材產業發展的限制，也成為本研究的重點之一。同時也以其他先進國家，美國、歐盟、日本為例，除了說明醫療器材產業之現況，並闡述各國政府於法規要求與策略方向，進而使得醫療器材廠商如何因應出不同的經營策略，並提出台灣醫療器材產業可行的發展策略，提供台灣中小型的醫療器材廠商做為參考的依據。;With the growth of population, all kinds of chronic disease population gradually increase, worldwide countries began to develop the medical industry. The demand for medical equipment has continued to increase. The variety of medical equipment products, and product before sales, it need to comply with a lot of regulations. Therefore, Taiwan manufacturers are difficult to enter the medical device market. This paper focus on Taiwan small and medium enterprise in medical industry. Assess the advantages and disadvantages of medical equipment industry for different regulatory restrictions and national regulatory trends. Let Taiwan small and medium enterprises to change business strategy. In the product development and design stage, adding the conditions of the regulations. Analyze the differences between different manufacturer conditions and regulatory conditions, and then develop a different business strategy. At present, most of Taiwan′s traditional electronics manufacturers want to invest in medical equipment industry, because the medical equipment industry is not affected by the economy. It is recommended to reduce the differences between the two laws and regulations, that to avoid the development of Taiwan′s medical equipment industry restrictions, has become one of the focus of this study. Take other countries as an example：United States, the European Union, Japan. Indicating the status of medical equipment industry in various countries, and explain the requirements of the government for regulatory requirements and strategic direction. Medical equipment manufacturers how to deal with a different business strategy, and put forward the Taiwan medical equipment industry feasible development strategy, take Taiwan′s s small and medium enterprise medical equipment manufacturers as reference.
顯示於類別:	[工業管理研究所 ] 博碩士論文

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