• Title/Summary/Keyword: Medical device legislation

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A Study on Regulatory Law for Management System of Combined Medical Device (결합 의료기기 관리제도의 규제관련 법률에 관한 연구)

  • Choi, Yong Jun;Choi, Mi Lim;Lee, Jeong Chan;Jung, Yong Gyu
    • 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.

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A Study in the Crimes of the Medical Practice without License - Case of Oriental Medicine's use of Ultrasounds - (무면허의료행위에 대한 형사법적 쟁점 - 한의사의 초음파기기 사용을 중심으로 -)

  • Jang, Jun Hyuk
    • 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.

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Should Korean Medicine doctors use modern diagnostic medical devices? Survey result of public perspectives (국민인식을 기초로 한의사의 현대 진단의료기기 사용 법제화 필요성에 대한 제언 : 설문조사를 중심으로)

  • Juchul Kim;Byoungcheun Hwang;Manki Hwang;Seungmin Kathy Lee;EunHee Yi;Jungtae Leem
    • The Journal of Korean Medicine
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    • v.43 no.3
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    • pp.94-105
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    • 2022
  • Objectives: This study investigated public opinion on the use of modern diagnostic medical devices by Korean Medicine doctors. Methods: A questionnaire looking into perceptions on the use of modern medical devices was developed. It was distributed by a third party and data was collected. Results were analyzed through frequency analysis, chi-square analysis (χ2-test), frequency and cross analysis using R program. The measurement variable in the study was the respondent's perspectives and expectations on the use of modern diagnostic medical devices by Korean Medicine doctors. The maximum significance level was 0.05. Results: There were a total of 3,000 responses and 80.8% of the respondents replied that there is a need for government-level discussion on endowing rights to Korean Medicine doctors as supervisors for safety management of radiation generating devices. Also, 83.3% of the respondents agreed the use of ultrasound imaging equipment in Korean Medicine clinics should be legalized. Conclusions: According to this study, respondents strongly support the use of modern diagnostic medical devices by Korean Medicine doctors. This is the first study to investigate public opinion in this area and it provides a significant insight into the public needs and desires for a wider scope of practice for Korean Medicine in the healthcare system.

Study on the Improvement of Relevant Legislative System for Activating Research Equipment Industry (연구장비산업 활성화를 위한 관련 법제 개선방안에 대한 연구)

  • Baek, Woonil;Han, Gapun
    • The Journal of Society for e-Business Studies
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    • v.25 no.2
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    • pp.127-146
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    • 2020
  • Overseas advanced countries are aware of the importance of research equipment and are providing a lot of policy support to revitalize the research equipment industry. However, Korea does not have any law to support policies or related projects to revitalize the research equipment industry. Therefore, there is an urgent need for legislation to support policies and projects for revitalizing research equipment industry. It is considered necessary to establish a separate special law for revitalizing the research equipment industry so that it can gain competitiveness in the global market of the research equipment industry. As we have seen, the necessary articles in the relevant laws should be specified so that various promotion policies can be developed to foster the research equipment industry. In order to promote the development of research equipment industry, there are three essential items to be specified in the law. First is research and development support, second is infrastructure development, and third is business incubation. The following contents should be included in each contents. First of all, "research and development support" includes research and envelopment project promotion and support policy items, research equipment development trends and investment trends, joint research between industry, academia, And research and development support for fusion, hybrid and commercialization. Next, the items to be included in "infrastructure development" should include the establishment of research equipment clusters, related support items, training of professional manpower, and research equipment development base area and institutions. Finally, the items that should be included in "business incubation." include support matters for the development of excellent companies (priority purchase system, etc.), matters related to technology transfer and marketing, matters concerning the protection of intellectual property, And matters for promoting overseas expansion.