• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.59
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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.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.64
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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.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.75
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• pp.159-177
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• 2017

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.

• The Korean Society of Law and Medicine
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• v.6 no.2
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• pp.187-234
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• 2005

• The Korean Society of Law and Medicine
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• v.15 no.2
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• pp.63-89
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• 2014

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

• The Korean Society of Law and Medicine
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• v.15 no.1
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• pp.35-57
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• 2014

Recently, there has been fierce argument between oriental and western doctors in the medical field. The use of medical devices has particularly come to the fore lately. Appropriate medical devices are required to diagnose and treat patients' conditions or illnesses accurately. At issue recently in medical device sector are diagnostic instruments using radiation, magnetic resonance imaging, ultrasound, IPL(Intense Pulse Light), and instruments used for tonometry. Relating to this issue, Association of Korean Oriental Medicine and The Association of Korean Medicine are sharply opposed. It is predicted that more accusations of this kind will be seen in the future. As oriental medicine contends, ultrasonic imaging itself seems to cause no harm to humans and its use may have an advantage for national health. The use of western diagnostic equipment can expand the diagnostic range of oriental doctors. However, unless new legislation is made, it is against the law for oriental doctors to use this equipment. Both law and medical science require grounds and predictability on the correctness of a decision and all of its consequences. Additionally, oriental medicine's use of ultrasounds and other medical devices should be established by standards and grounds which make same the diagnosis with repetition. Therefore, the scope of oriental medicine can be expanded following a revision of the Oriental Medicine Promotion Act and it is estimated that the state of national health will be greatly improved by the mutual respect of both sides of the health profession.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.45
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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.

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

• Journal of Service Research and Studies
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• v.4 no.2
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• pp.1-10
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• 2014

According to recent trends in technological advances and globalization, medical device industry may improve the constitution to meet worldwide medical equipment management system. Also it is holding a strand of mitigation to reach the level of international regulation. In addition, recent legislation tends are to stay limited ranges of industry regulations at least and take as open attitude for integration of new technologies combined medical devices. A greater environmental risk is not likely to work in medical technology, Combinded medical device is used as close to zero risk in most of the human body, which is classified as Class 1. Even medical device such as little or no risk in handling, it is possible to minimize the unnecessary administrative power and a waste of time to occur. For the medical device may be improving people's choices and access, medical equipment operator is expanding to include dealers, because this will be exalted to particular area of the business of the company. In this paper, we investigate the legal prerequisites for the establishment of a medical device. And propose improved regulations in topics in order to facilitate the repair and distribution markets for fair trade.

• Journal of Korean Dental Hygiene Science
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• v.1 no.1
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• pp.23-36
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• 2018

This research has been conducted from June 1, 2017 to August 25, 2017 for the dental hygienists working in Busan and Gyeongnam area, to provide necessary basic data for the purpose of revision of the relating laws from the analysis of their understanding and perspective on such laws through 262 subjects' questionnaire. Its analysis of their perspectives are as follows. 1. The common characteristics of the subjects are that 40.1% of them are under 25, and their working period was under three years with the 38.9%, and as for their marital status, 70.2% were single, the final education of 80.2% were associated degrees. Their working areas are centered in Gyeongsangnam-do province with 91.2%, the workplace type is for the dental clinic with 80.2%. 2. The comparison of the view point of the medical(technician) law according to the characteristics of the research subjects differed only whether or not the completion of the education, and as a result of the comparison according to the characteristics of those subjects understanding the details of the medical(technician) law, there was a significant difference saying "the current law has clear job description" depending on the working area or "the job duty is definite" depending on the job experience and job details. As for those saying "the job duty is definite", there was also significant difference depending upon marital status, final education and work details. There was no significant difference in all characteristics from findings of the necessity of legal system according to the subjects not understanding the medical(technician) law. 3. As a result of comparing the necessity of the medical(technician) law according to the characteristics of the research subjects, it was found that all the subjects accepted the necessity of the medical law revision including the dental hygienist in the medical person. The "necessity of the professional dental hygienist system" showed a significant difference depending upon the final education and medical institution type. Among the triggering factors in its amendment, there showed significant difference in the "cooperation of other organizations" and "solution of medical law problems" only in the final education. 4. As a result of comparison of the needs of the medical(technician) law revision according to the characteristics of the research subjects, it was found that the significant traits related to the age and job details showed "Legal responsibility would be increased" when the medical law is revised, in case that "it will help broaden the job extension", there showed a significant difference in career, final education, and working institution, and job details. "Legal protection is possible" showed significant difference except the age group and working area, and "it help the system settlement" showed in the final education. There was a significant difference in career, final education, and job details that "I can regulate the education and field practice", and the same in "my status will be improved" depending upon the final education, work area, and job details. Accordingly, in this research, for the establishment of more professional and comprehensive dental health service as suggested from the demand and necessity toward the medical(technician) Law by the dental hygienists.