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한국 의료기기산업의 국제경쟁력 제고방안에 관한 연구

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Author(s)
고휘석
Issued Date
2011
Abstract
The purpose of this study is to propose measures to enhance the international competitiveness of medical device industries in Korea. By analyzing the status and international competitiveness of medical device industries in Korea, this study also intends to demonstrate how to promote them as future core strategic industries.
An analysis of the status of Korea's medical device industries in 2010 shows that the size of medical devices' market is about 4 trillion won and has been steadily growing at an average rate of more than 20% per year. The total value of imported medical devices is $ 2.27 billion while that of exported medical devices is $1.45 billion. In addition, the trade deficit reached 938.2 billion won in 2010, which is 6.5 percent more than in the previous year.
The total value of production in domestic medical devices increased by 7.24 percent, to about 3 trillion won, compared to the previous year. Furthermore the market share of domestic medical devices is 43.7 percent. However, despite recent growth the medical device industry in Korea is expected to face future difficulties as the local market share of imported devices is increasing while tariffs have been eliminated under the system of FTA.
An close analysis shows that the international competitiveness of our nation's medical device industry is inferior to that of global corporations in all aspects: capital, technology, human resources, brand recognition, etc. Furthermore, small enterprise is facing difficulty creating new demand due to the domestic medical authority's preference for foreign-made medical devices and discrimination against domestic products.
In terms of the system, external forms are international, but many internal institutions do not correspond with international standards. Furthermore, internal systems do not correspond to the development of innovative technologies such as complex medical devices combined with IT and BT and the beginning of U-health. Therefore, the laws in these area need revising.
An analysis conducted using Porter's diamond model shows that although Korea's international competitiveness received a relatively high evaluation in terms of the associated and support industry(production inducement coefficient), it ranked the lowest compared with developed countries. This analysis shows the weakness of Korea's international competitiveness. This is reflected in Korea's global market share which, though increasing, remains under 1 percent.
Ferto and Hubbard RCA indexes of Korea, Japan and China are all lower than zero. This indicates all countries are under a comparative disadvantage, but among them, China and not Korea, has the highest competitiveness.
An analysis of the MSER-ESDR index shows that there was a small increase in the market share of Korea's medical device industries in the US compared to China. It also indicated that Korea's export commodities have become similar to those of China, resulting in a continuing weakening of Korea's competitiveness.
Based on these analyses of the medical device industries in Korea, enhancing measures include changing discriminatory practices against domestic products which is related to improving the conditions of competition, enhancing cooperation between producers and consumers, and strengthening small enterprise of medical devices. Also, enhancing the capacity to develop the industries, preempting a promising new market, building collaborative scheme in global markets, and finding a new market, would all be effective measures for expanding the basis of industrial development and preempting a new market.
Finally, the operation of third party certification system, the differentiation of management system, the adoption of GMDN System, the activation of certification in GMP, and the improvement of the legal framework would advance the medical equipment management system.
Alternative Title
A Study on Measures to Enhance the International Competitiveness of Medical Device Industries in Korea
Alternative Author(s)
Ko, Huee-Seok
Affiliation
조선대학교 대학원
Department
일반대학원 무역학과
Advisor
이성민
Awarded Date
2012-02
Table Of Contents
【목 차】
ABSTRACT
제1장 서 론 1
제1절 연구배경 및 목적 1
제2절 연구의 범위 및 방법 3
제3절 선행연구 검토 5

제2장 의료기기산업의 개요와 관리제도 8
제1절 의료기기산업의 개요 8
1. 의료기기산업의 정의 및 특성 8
2. 의료기기산업의 분류 방법 10
3. 국제 의료기기 명명체계 16
제2절 의료기기산업의 관리제도 18
1. 주요국의 의료기기 관리제도 18
2. 한국의 의료기기 관리제도 24

제3장 의료기기산업의 현황 및 문제점 30
제1절 세계 의료기기산업의 현황 30
1. 의료기기산업의 환경 30
2. 세계 의료기기산업 동향 34
3. 주요 국가별 동향 38

제2절 한국 의료기기산업의 현황 44
1. 한국 의료기기산업 개황 44
2. 한국 의료기기산업 생산 현황 46
3. 한국 의료기기산업 수출입 현황 52
제3절 한국 의료기기산업의 문제점 62
1. 경쟁여건 측면 62
2. 산업기반 측면 64
3. 제도적 측면 66

제4장 한국 의료기기산업의 국제경쟁력 분석 69
제1절 경쟁력 지표의 이론적 고찰 69
1. 국제경쟁력의 정의 69
2. 국제경쟁력 상관 이론 71
3. 국제경쟁력 평가에 관한 이론 77
제2절 다이아몬드 모델을 통한 경쟁력 분석 84
1. 분석모형의 개념 84
2. 분석지표의 선정 및 데이터 수집 89
3. 국제경쟁력 분석 결과 91
제3절 국제경쟁력 평가지수를 통한 분석 98
1. 분석대상 및 데이터 수집 98
2. MS, RCA, ESI를 통한 국제경쟁력 분석 100
3. MSER-ESDR을 통한 국제경쟁력 분석 116

제5장 한국 의료기기산업의 국제경쟁력 제고방안 134
제1절 국내 경쟁여건의 개선 134
1. 국산제품에 대한 차별적 관행 개선 134
2. 생산자와 수요자 협력 강화 136
3. 의료기기 중소제조기업 지원 강화 138
제2절 산업기반의 확충 및 신시장 선점 139
1. 산업발전 역량의 강화 139
2. 유망 신산업 시장의 선점 142
3. 글로벌 협업체계 구축과 신규시장 개척 145
제3절 의료기기 관리체계의 선진화 150
1. 제3자 인증제도의 시행 150
2. 의료기기 관리체계의 차별화 151
3. GMDN System 채택과 GMP인증 활성화 154
4. 규제의 완화 및 법제도 개선 156

제6장 결 론 158
Degree
Doctor
Publisher
조선대학교 대학원
Citation
고휘석. (2011). 한국 의료기기산업의 국제경쟁력 제고방안에 관한 연구.
Type
Dissertation
URI
https://oak.chosun.ac.kr/handle/2020.oak/9482
http://chosun.dcollection.net/common/orgView/200000257008
Appears in Collections:
General Graduate School > 4. Theses(Ph.D)
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