• 제목/요약/키워드: Medical Device Market

검색결과 91건 처리시간 0.03초

의료기기산업의 수출경쟁력 분석 및 강화방안 -강원지역 의료기기산업을 중심으로- (The Analysis and Strengthening Method of Export Competitive Power of Medical Device Industry - With Respect to Medical Device Industry in Gangwon Area)

  • 이강빈
    • 무역상무연구
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    • 제45권
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    • pp.191-238
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    • 2010
  • The purpose of this paper is to make research on the trend of the worldwide medical device market, the trend of the medical device market in the major foreign countries, the present status of the medical device industry in Korea and Gangwon area, the present status of export competitive power and the SWOT analysis of competitive power of the medical device industry in Gangwon area, and the strengthening methods of export competitive power of the medical device industry in Gangwon area. As the research method, the questionaire for the strengthening of export competitive power of the medical device industry in Gangwon area was carried out from August 13 to Otober 22, 2009. The worldwide medical device market in 2008 is estimated at USD 210.2 billion, with the United States being the largest market, followed closely by Japan and Western Europe. In 2006, the worldwide export amount of medical devices recorded USD 121.1 billion and the worldwide import amount of medical devices recorded USD 126.3 billion. As of the end of 2008, the number of Korea's medical device manufacturers expanded to 1,726. The production amount of Korea's medical device industry in 2008 recorded 2,525 billion won, and the domestic market volume of medical devices in 2008 recorded 3,618 billion won. Korea's export amount of medical devices in 2008 recorded USD 1,132 million and recorded a 9.67% growth compared to the previous year, and the import amount of medical devices recorded USD 2,123 million and recorded a 1.43% reduction compared to the previous year. As of the end of 2008, the number of Gangwon area's medical device manufacturers expanded to 81. The production amount of Gangwon area's medical industry in 2008 recorded 380 billion won, and Gangwon area's export amount of medical devices recorded USD 269 million and recorded a 0.25% reduction compared to the previous year, and the import amount of medical devices recorded USD 3 million and recorded a 39.63% reduction compared to the previous year. According to the result analysis of the questionaire for the strengthening of export competitive power of medical device industry in Gangwon area(August 13~October 22, 2009), the competing country of the export medical device is the United States being the highest ranking. Comparing to the collective competitive power level 100 of the competing country, the collective competitive level of the export medical device is 60 below and 70-80 below being the highest ranking. Comparing to the quality level 100 of the United States, EU and Japan, the quality level of the export medical device is 80-90 below being the highest ranking. Comparing to the design level 100 of the United States, EU and Japan, the design level of the export medical device is 90-100 below being the highest ranking. Comparing to the technology level 100 of the United States, EU and Japan, the technology level of the export medical device is 80-90 below being the highest ranking. According to the SWOT analysis of competitive power of medical device industry in Gangwon area, the strength is the abundant expert manpower of the medical device in Wonju area. The weakness is the fragility of the brand recognition of the medical device industry. The opportunity is the demand increase of the new medical device owing to the advanced age of population. The threat is the difficulty of entry into overseas market owing to the request of the new specification certification of the medical device. In order to strengthen the export competitive power of the medical device industry in Gangwon area, the following measures should be taken by the government, local self-government body, related organization and medical device industry : the development of new technology and design, the enhancement of brand recognition. the acquisition of the foreign specification certification, the building of overseas distribution channel and after sales service channel, the positive participation in overseas medical device exhibition and opening of medical device exhibition, the training of expert manpower, the strengthening of overseas marketing, and the application of FTA and the establishment of counter measures against FTA. In conclusion, the medical device industry in Gangwon area has the difficulty in the entry into the overseas market owing to the shortage of overseas marketing capability. Therefore, the government and local self-government body should make the intensive and systematical support for overseas marketing of the medical device industry. For the support of overseas marketing, the government and local self-government body should provide positively the support of expenses for the acquisition of foreign specification certification, the support of participation in the overseas medical device exhibition, the despatch of market development mission, the increase of the support amount for R&D investment fund, and the training of expert manpower of medical devices.

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한.미.중 의료기기에 관한연구 (A Study on the Medical Devices in Korea, U.S., and China)

  • 배홍균
    • 무역상무연구
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    • 제59권
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    • pp.181-205
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    • 2013
  • This study has analyzed the international trade flow of medical devices in Korea, China, and U.S. more theoretically and systematically through a mutual connection of the medical device export structure of Korea and the import structure of China and U.S. organically, with an intensity approach on the bilateral international trade flow. Also, it is meaningful to find a solution to boost exports of Korea to China and U.S.. Therefore in this study, we recognize the importance of the medical device market in China and U.S., which is the main competition for Korea and its market, and look into the trade situation of these three countries. We also look into the relative market stream and the trade intensity of the main medical devices in Korea, China and U.S., and seek measures for the steady growth of the medical device market in these three countries.

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A Study on the Market of Imported Medical Devices in Myanmar

  • Bae, Hong Kyun
    • 무역상무연구
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    • 제64권
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    • pp.213-237
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    • 2014
  • The medical-device market of Myanmar in the recent Asian region is where the influences of Thailand, China, India and Singapore are being shown considerably with the lift-up of economic sanctions by America and the West. However, although the global capital and liberalization have widened the openness and the international concerns, the relative Myanmar's medical environment demands an active assistance and improvement. The study, recognizing the importance of Medical-Devices and their market conditions emerging as key business for knowledge-based industry, aims to obtain consequential meaningful suggestions, pursuant to relative export-concentration and sustainable market growth of Medical Devices, by analyzing inter-nation trade intensity for key Medical Device items. To do so, this study selected 8 nations in total by reviewing three points: core Medicine-advanced countries, geographically adjacent countries to Myanmar, and relative export-concentration.

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한국 의료기기 산업의 역사와 국제 경쟁력 고찰 (A Study on the History of the Korean Medical Device Industry and its Global Competitiveness)

  • 염호준;정현우;박상수
    • 문화기술의 융합
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    • 제8권5호
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    • pp.1-7
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    • 2022
  • 한국의 의료기기 산업은 1995년부터 시작된 G7 의료공학기술개발사업으로 본격적인 성장과 발전의 기틀을 마련하였으며 2020년 한국 의료기기 생산실적은 2001년에 비하여 8.52배, 수출 실적은 13.94배 성장하였다. 의료기기 국산화 개발 초기에 초음파 의료기기 등 전자 의료기기의 개발이 활발하였던 것과 비교하여 2020년에는 체외진단시약과 치과용 임플랜트의 생산 및 수출 실적이 상위권을 차지하고 있다. 그러나 한국 의료기기 시장에서 수입 의료기기가 차지하는 비중은 60-70%에서 큰 변화가 없는데 이는 한국의 의료기기 산업이 중저가 의료기기를 생산 수출하고, 기술집약적이고 자본집약적인 고가 의료기기는 주로 수입에 의존하고 있기 때문이다. 본 논문에서는 한국과 세계시장의 주요 의료기기 회사들의 생산 품목을 비교하여 한국 의료기기 산업의 세계 시장 진출에 대한 전략을 제시하고자 한다.

한방의료기기의 미국 시장 진출을 위한 심사제도 소개 (The registration and approval of Oriental Medical devices for the entry into U.S. market)

  • 오지윤;최유나;조수정;정찬영;조현석;이승덕;김갑성;김은정
    • Journal of Acupuncture Research
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    • 제32권4호
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    • pp.91-102
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    • 2015
  • Objectives : The Oriental medical device industry is expected to continue to experience significant growth. It should increase its global market share rather than focusing on the domestic market. Countries around the world self-regulate their domestic market, so this study aims to aid in the development of a particular overseas market by introducing the U.S.(the largest market) medical device registration and approval process. Methods : For an understanding of the US medical device licensing process, we researched the relevant regulatory organization (FDA), the history, definition and classification of medical devices, the approval and 510(k) submission process related to substantial equivalence, IEC 60601-1 Edition 3, usability tests, and so on. Results : Medical devices in the United States are assigned to one of three regulatory classes: Class I, Class II and Class III, based on the level of control necessary to assure the safety and effectiveness of the device. If a company's device is classified as Class II and if it is not exempt, a 510k will be required for marketing. 1) A 510(k) is a premarket submission made to the FDA to demonstrate that the new device to be marketed is "substantially equivalent" to a legally marketed device (predicate device) 2) The IEC 60601-1 Edition 3 preparation process, which contains information related to usability, is expensive and time-consuming but a critical requirement. Conclusions : Although the U.S. market has high barriers to entry, access to this, large overseas market will encourage development of the Oriental medical device industry and commercial value enhancement is expected.

의료기기 이상사례 보고에 대한 국내 이해관계자의 관점 차이 (Perspective Diversity of Domestic Stakeholders on Medical Device Adverse Event Reporting)

  • 이예진;윤치호;최수정;강영준;김진국;권범선;이유경;남기창
    • 대한의용생체공학회:의공학회지
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    • 제40권5호
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    • pp.171-178
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    • 2019
  • This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.

한.중.일 의료기기 무역분석 (Analysis on international trade flow of medical devices in Korea, China, and Japan)

  • 배홍균
    • 통상정보연구
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    • 제14권4호
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    • pp.131-152
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    • 2012
  • 본 연구는 2국간 의료기기무역흐름(international trade flow)에 관한 무역결합도이론(Intensity Approach)을 통해 우리나라의 의료기기수출구조(export structure)와 중국과 일본의 수입구조(import structure)를 상호유기적으로 연계시킴으로써 한 중 일 의료기기 무역의 흐름을 보다 이론적이고 체계적으로 분석하였다. 또한, 우리의 대중국과 일본의 의료기기 수출증대(boost exports)에 기여할 수 있는 방안을 모색하는데 의의가 있다. 이에 본고에서는 한국과 의료기기(medical device) 시장에서 주요한 경쟁관계에 있는 중국과 일본의료기기 시장의 중요성을 인식하고 특별히 의료기기의 한 중 일 무역현황(situation of trade)을 살펴본다. 이어서 삼국의 의료기기에 있어서 상대적인 시장흐름(market stream)과 주요 의료기기 품목의 무역결합도(trade intensity)를 알아보고, 한 중 일 의료기기 시장의 지속적인 성장방안을 찾고자 한다.

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시장지배적 의료기기 사업자의 경쟁제한적 차별행위 - 지멘스 사건을 중심으로 - (A Review on the Dominant Undertaking's Abuse in the Medical Device Market)

  • 정재훈
    • 의료법학
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    • 제23권1호
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    • pp.81-119
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    • 2022
  • 대상판결은 시장지배적 지위 남용에 관한 다양한 쟁점을 다루었을 뿐만 아니라, 경쟁제한효과가 문제된 시장이 의료기기 시장이라는 측면에서도 여러 시사점을 제시하고 있다. 첫째, 관련상품 시장의 측면에서 대상판결이 주상품(CT, MRI 등 의료기기) 시장과 부상품(유지보수서비스) 시장이 밀접하게 관련되어 있다고 하더라도 이를 하나의 시장으로 보기 어렵다고 판단한 것은 수긍할 수 있다. 둘째, 대상판결은 고착효과에 관하여 명시적인 판시를 하지 않았으나, 관련시장에 대한 판단에서 높은 주상품 가격, 주상품의 사용연한이 장기인 점 등을 고려하는 등 실질적으로 고착효과를 반영한 것으로 보인다. 셋째, 객관적 행위 요건으로 '정상적인 거래관행에 반하는 타당성 없는 조건'에 대하여 대상판결은 저작권자가 실시료를 받고 저작권을 실시하는 행위는 정당한 권리행사이며, 원고가 유상의 라이선스 정책을 가지고 이를 실행하며, 예외적인 경우에만 무상으로 실시를 하였으므로 공정위가 주장하는 무상실시 관행을 증거로 인정할 수 없음을 지적하였다. 넷째, 이 사건에서 경쟁자의 비용 상승은 원고가 서비스 소프트웨어 사용에 필요한 서비스키를 유상으로 제공한 행위를 통하여 이루어졌고, 원고의 행위가 지식재산권의 행사로 정당하다면 설령 그러한 행위로 경쟁이 제한된다고 하여 이를 남용행위로 보기는 어렵다고 판단하였다. 대상판결이 다룬 관련시장의 획정, 시장지배력의 존부, 객관적 행위 요건, 경쟁제한효과 등 주요 쟁점에 대하여 대법원이 시장지배적 지위 남용행위의 증명기준과 증명도의 방향을 제시할 기준을 판시할 것으로 기대한다.

우리나라 의료기기산업의 대중국 경쟁력 연구 (The competitiveness study of Korea Medical Device Industry in China)

  • 이유아;정윤세
    • 통상정보연구
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    • 제17권3호
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    • pp.93-114
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    • 2015
  • 본 연구에서는 중국시장에서 우리나라의 국제경쟁력을 보유한 수출특화품목을 도출하기 위하여 RCA지수, MCA지수, TSI지수를 통해 우리나라와 중국 의료기기산업의 국제경쟁력을 분석하였으며 도출된 국제경쟁력 지수를 그룹화하고 연도별로 변화추이를 살펴보았다. 우리나라는 중국시장에서 우리나라 의료기기 품목의 경쟁력을 강화하기 위하여 지속적으로 중국 의료기기 시장 동향을 분석하고 중국시장에서 우리의 시장점유율과 경쟁우위를 파악하여 수출특화품목을 도출하고 발굴해야 할 것이다.

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의료기기의 해외시장 진출방안에 관한 연구 (The Strategy of Overseas Market Entry of Medical Device)

  • 정재호
    • 한국콘텐츠학회:학술대회논문집
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    • 한국콘텐츠학회 2009년도 춘계 종합학술대회 논문집
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    • pp.1210-1215
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    • 2009
  • 최근 국내 의료기기산업은 선진국에 비해 빠른 성장을 지속하고 있고, 기술수준도 점차 향상되고 있다. 그러나 국내 산업은 높은 수입비중, 낮은 투자여력, 전문인력 부족 등 전반적인 경쟁여건은 여전히 취약한 문제점으로 나타났다. 이에 본 연구에서는 세계 의료기기시장과 산업에 대해 살펴봄으로써 의료기기 산업의 발전방안을 모색하였다. 또한 의료기기 수출확대방안으로 단기적인 정책의 효과보다는 중장기적인 접근이 필요하며, 정부의 제도 개선 및 지원, 영세성을 극복할 수 있는 생산단지 클러스트화. 시장세분화 및 해외마케팅 강화 등이 필요하다고 하겠다.

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