• THE INTERNATIONAL COMMERCE & LAW REVIEW
• /
• v.45
• /
• pp.191-238
• /
• 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.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
• /
• v.59
• /
• pp.181-205
• /
• 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.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
• /
• v.64
• /
• pp.213-237
• /
• 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.

• The Journal of the Convergence on Culture Technology
• /
• v.8 no.5
• /
• pp.1-7
• /
• 2022

Korean medical device industry has laid the foundation for full-fledged growth and development with the G7 medical engineering technology development project that started in 1995, and the medical device production in 2020 increased by 8.52 times and the export by 13.94 times, compared to those in 2001. In early years, electronic medical devices such as ultrasound imaging device contributed greatly to Korean medical industry, but top ranks in medical device production and export in Korea has shifted recently to in vitro diagnostic medical devices and dental implants. However, the share of imported medical devices in the Korean medical device market have not changed much; it still ranges in 60 to 70%, as the Korean medical device industry produces and exports mid- to low-priced medical devices, and technology-intensive and capital-intensive high-priced medical devices are mainly imported. In this paper, we compare the leading medical devices produced by major Korean companies and those by global top medical device companies to suggest strategies for the Korean medical device companies to enter the global market.

• Journal of Acupuncture Research
• /
• v.32 no.4
• /
• pp.91-102
• /
• 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.

• Journal of Biomedical Engineering Research
• /
• v.40 no.5
• /
• pp.171-178
• /
• 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.

• International Commerce and Information Review
• /
• v.14 no.4
• /
• pp.131-152
• /
• 2012

This study has analyzed the international trade flow of medical devices in Korea, China, and Japan more theoretically and systematically through a mutual connection of the medical device export structure of Korea and the import structure of China and Japan 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 Japan. Therefore in this study, we recognize the importance of the medical device market in China and Japan, 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 Japan, and seek measures for the steady growth of the medical device market in these three countries.

• The Korean Society of Law and Medicine
• /
• v.23 no.1
• /
• pp.81-119
• /
• 2022

Medical device market is strongly related with health care market. Public regulation in medical device market tends to be more lenient than health care market. In this market, competition law, administrative law and intellectual property law are intertwined, and thereby a variety of legal issues could be developed. Recently, dominant undertaking's abuse case was dealt with KFTC(Korea Fair Trade Commission) and Seoul High Court. The issues were whether dominant undertaking discriminated trading partners and this discrimination was anticompetitive. In this case, Seoul High Court revoked the KFTC's decision, holding that the undertaking did not harm competition, though it has dominant power in the relevant medical device market. This decision would be a meaningful precedent, not only that there have been small numbers of dominance abuse cases in Korea, but also that this case happened in medical device market. This case dealt with various issues like market definition, market power, alleged abuse and its anticompetitive effect. The court held that medical device markets are distinguished from medical device repairing market. However, the court did not clarify that medical device repairing market is a single branded market only for repairing the plaintiff's medical devices. Second, plaintiff's dominance is based on the lock-in effect, which means that hospitals could not switch devices like CT or MRI from plaintiff to other competitors. This could be supplemented from the fact that medical devices are expensive and the using period are significantly long. However market definition based on single branded market theory could be applied in rare and exceptional cases. Therefore the general application of single branded market theory might result in overestimate of market power. This type of abuse pattern requires improper condition contrary to resonable trade practice. KFTC asserted free charge for plaintiff's copy right. However, it is not clear whether the cases for free charge are general or not. Even if so, the intention and motive of providers for free charge should be proved. The main issue of anticompetitive effect was whether plaintiff raised rival's cost. Competitor's cost was increased due to plaintiff's copy right and its license fee. However the charge for license could be within the scope of fair and legal exercise of copy right. If competitors are excluded due to legal exercise of copy right or efficiency, the exclusionary abuse could not be proved.

• International Commerce and Information Review
• /
• v.17 no.3
• /
• pp.93-114
• /
• 2015

In this study, the national competitiveness of Korean and Chinese medical device industry was analyzed through RCA index, MCA index, and TSI index in order to draw the export specialized items possessing the national competitiveness of Korea in Chinese market. The drawn national competitiveness index was grouped and the change progress was examined by years. Korea should analyze the tendency of Chinese medical device market, confirm our market share in the Chinese market, apprehend the competitive superiority, and draw and excavate the specialized export item in order to strengthen the competitiveness of Korean medical device in the Chinese market.

• Proceedings of the Korea Contents Association Conference
• /
• 2009.05a
• /
• pp.1210-1215
• /
• 2009

The domestic medical device industry compared by advanced nations continues a quick growth, also the level of technique is gradually improving. However, the high import percentage, low investment, shortage of professional manpower and etc. are remained as weaknesses in the competitive circumstance. In this paper I researched world medical device market and industry, and tried to find the development plan of the domestic medical device. The approach could be in mid-long term rather than short-term, The institutional improvement and support of the government, the production complex, the market segmentation and overseas marketing reinforcement and etc. are necessary for export expansion plan.