글로벌 의료기기산업의 시장동향 및 주요 수출국의 의료기기 관련 규제에 관한 연구 = A Study on Global Medical Device Market Trends and Regulation of Medical Equipment in Major Countries

다국어 초록 (Multilingual Abstract)

In this paper, we examined trends and regulations of the global medical equipment industry through literature search.
The medical equipment industry is attracting attention as a new growth engine in the Fourth Industrial revolution. However, the medical device industry is a highly competitive field due to product diversity, short product life cycle and technological advances. In addition, Medical equipment are related to human health and safety. Therefore, it can only be exported if it is approved by national or international standards. Therefore, from the development stage of the product, the medical equipment should designate the country to be exported and develop a medical equipment that meets the requirements for licensing the medical equipment in the country. Therefore, In this paper, In this paper, we will present the practical considerations of the medical equipment exporting company by examining the global medical equipment market trends and the regulations related to medical equipment in major countries.

목차 (Table of Contents)

• Ⅰ. 서론
• Ⅱ. 의료기기산업에 관한 일반적 고찰
• Ⅲ. 글로벌 의료기기산업의 시장동향
• Ⅳ. 주요 수출국의 의료기기산업에 관한 규제
• Ⅴ. 결론
• 참고문헌
• ABSTRACT

참고문헌 (Reference)

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3 이강빈, "지역특화 의료기기 산업의 수출 활성화 방안" 한국국제상학회 20 (20): 239-271, 2005

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6 의료기기정보기술지원센터, "의료기기백서" 2016

7 이유아, "우리나라 의료기기산업의 대중국 경쟁력 연구" 한국통상정보학회 17 (17): 93-114, 2015

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9 "https://www.dailymedi.com/detail.php?number=778842&thread=22r08"

10 MPO(Medical Product Outsourcing), "Top Medical Device Companies, 2014~2015" 2014

11 BMI Espicom, "The World Medical Markets Factbook 2016" 2016

12 Lawton R, Burns, "The Business of Healthcare Innovation" Cambridge University Press 2005

13 한국보건산업진흥원, "FDA 의료기기 인허가 과정에서 발생하는 특허분쟁 케이스" 2014

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15 한국보건산업진흥원, "2015년 의료기기산업 분석보고서" 2015