臺灣博碩士論文加值系統

醫療器材產業具有科技、知識高度密集之特性，近年來產值呈現2位數的成長，2004年台灣醫療器材產業的產值為新台幣504億元，而出口值則為新台幣276億元；預期至2011年，台灣的醫療器材產值可達到2,000億台幣。為了提升醫療服務品質，衛生署訂定發布「特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法」，但其中對中醫醫療器材相關規定相當不足，近年來由於科技的發達在中醫應用上無論是診斷或治療都運用了許多的儀器，但是相關醫療器材在認證規定販售及操作人員的資格方面都沒有明確的規範，故本研究針對國內外文獻及政府單位制度的研究與國內業者及銷售人員醫師的問卷調查，並使用AHP的統計分析方式，找出一套較完整的中醫醫療儀器使用資格的建議，使得中醫的醫療及研究未來可以科學化。

There are technology and knowledge-intensive properties in the medical equipment industry. Its output grows up double in recent years. Output of medical equipment industry in Taiwan in 2004 is NT$50.4 billion and export value is NT$ 27.6 billion. We expected the output of medical equipment in Taiwan to achieve NT $200 billion by 2011. In order to advance the quality of medical services, the Department of Health, Executive Yuan issued "specific medical technology inspects of administration of medical equipment or uses management approach ", but it has not enough relevant regulations of medical equipment in Chinese medicine. The application of Chinese medicine uses a lot of equipments for diagnosis or treatment due to technological development in recent years, but certification of relevant medical equipment has not definite clearly standard of selling and operators’ qualifications. This study focuses on the research of domestic and foreign literatures and government agency system, and questionnaires of domestic dealer and physician. And this study used Analytic Hierarchy Process (AHP) to find a complete set of the operation qualifications of the medical equipments in Chinese medicine. It can make medical and research in Chinese medicine scientific in the future.

ACKNOWLEDGMENTS i
ENGLISH ABSTRACT iii
CHINESE ABSTRACT iii
TABLE OF CONTENTS iv
LIST OF FIGURES vii
LIST OF TABLES vii
CHAPTER
I. Introduction 1
1.1 Research Background 1
1.2 Research Motivation 3
1.3 Research Objective 3
II. Literature Review 5
2.1 Related literature of medical device 5
2.2 Related literature of medical 29
2.3 The study of the selling and qualification of the medical
equipment in Chinese medicine 33
III. Research Method 40
3.1 Research Design 40
3.2 Research Process 41
3.3 Research Subject 43
3.4 Research Method 43
Ⅳ. Empirical Analysis and Result 46
4.1 Expert Questionnaire of definition of the medical equipment in Chinese medicine 46
4.2 Pretest Questionnaire 49
4.3 Expert Questionnaire 57
Ⅴ. Conclusions and suggestions 79
5.1 Conclusion of this Research 79
5.2 Suggestions 81
REFERENCES 83
LIST OF FIGURES
Figure 3.1: Research process 41
Figure 3.2: Application process of analytical hierarchy processes(AHP) 45
Figure 4.1: Effect on the operation qualifications of the medical equipments in Chinese medicine after expert cut measurement framework 56
LIST OF TABLES
Table 2.1: The classification of medical equipments in Taiwan 7
Table 2.2: The different definition of all countries 8
Table 2.3: Medical device management structure in the domestic 11
Table 2.4: Classification of medical devices in Japan 19
Table 2.5: Classification of medical devices in European Union 23
Table 2.6: Description of GMP for manufacturers 25
Table 2.7: Describes the GMP control which must be practiced by medical equipments importers 26
Table 4.1: Definition of the medical equipment in Chinese medicine 47
Table 4.2: The medical equipment in Chinese medicine 48
Table 4.3: Rankings of frequency use of the medical device in Chinese medicine 48 Table 4.4: Related literatures 49
Table 4.5: Target of the questionnaire 52
Table 4.6: Determinants 53
Table 4.7: Evaluation criteria for manufacturer qualified for conditions 53
Table 4.8: Evaluation criteria for salesperson qualified for conditions 54
Table 4.9: Evaluation criteria for crucial level of using place of medical equipment in Chinese medicine 54
Table 4.10: Evaluation criteria for operator qualified for conditions 54
Table 4.11: Evaluation criteria for crucial level of training unit of medical equipment in Chinese medicine 55
Table 4.12: The questionnaires returning 57
Table 4.13: Target of questionnaire 57
Table 4.14: Key factors in weight order of the operation qualifications of the medical equipments in Chinese medicine 59
Table 4.15: Key factors in weight order of manufacturer qualified for conditions 60
Table 4.16: Key factors in weight order of salesperson qualified for conditions 62
Table 4.17: Key factors in weight order of using place 64
Table 4.18: Key factors in weight order of operator qualified for conditions 65
Table 4.19: Key factors in weight order of training unit 66
Table 4.20: The synthetic relative weight and the sequence of operation qualifications of the medical equipments in Chinese medicine—physicians 68
Table 4.21: Key factors in weight order of the operation qualifications of the medical equipments in Chinese medicine 69
Table 4.22: Key factors in weight order of manufacturer qualified for conditions 70
Table 4.23: Key factors in weight order of salesperson qualified for conditions 72
Table 4.24: Key factors in weight order of using place 74
Table 4.25: Key factors in weight order of operator qualified for conditions 75
Table 4.26: Key factors in weight order of training unit 76
Table 4.27: The synthetic relative weight and the sequence of operation qualifications of the medical equipments in Chinese medicine—dealers 78
Table 5.1: The first ten Key factors affecting the operation qualifications of the medical equipments in Chinese medicine 80
Table 5.2: The last ten Key factors affecting the operation qualifications of the medical equipments in Chinese medicine 81

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