• Journal of Biomedical Engineering Research
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• v.42 no.3
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• pp.86-93
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• 2021

Purpose: The purpose of this study is to find out the cognizance of medical device safety information (MDSI) monitoring in the hospital and oriental hospital workers, and the different aspect of MDSI between oriental medical devices and medical devices. Methods: The survey was performed both in the oriental medicine hospital and general hospital. The survey had 16 items; 2 items basic questions, 5 items in the awareness of MDSI, 5 items in the education of MDSI, 4 items in the necessity of defining oriental medical devices and differences between general and oriental medical devices. A total of 120 hospital worker were participated; 60 oriental medicine hospital workers and 60 general hospital workers. They had worked in the oriental medicine or general hospital associated with 'Medical Device Safety Monitoring Center, Dongguk University Ilsan Hospital' in 2019 and 2020. Results: The cognizance of MDSI was high both in oriental medicine hospital and general hospital workers and there were no significant differences between oriental medicine and general hospital workers. When we divided the hospital workers into the senior workers who had worked for over 3 years and junior workers for less than 3 years, the senior workers had higher awareness of MDSI than junior workers. However, the cognizance of education of MDSI was high which was not different between senior and junior workers. Both hospital workers thought that it was necessary to define oriental medicine device legally and the oriental medical device might have low risk and less side effect than medical device. Conclusion: The cognizance of MDSI was high and there was no significant differences between oriental medicine and general hospital workers. Because the senior hospital workers had higher recognition of MDSI, we need to provide the continuous education program for junior hospital workers. Although oriental medical device are thought to be safer than medical device, we need to have a legal definition.

• Journal of Acupuncture Research
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• v.32 no.4
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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.

• Journal of Korean Medicine Rehabilitation
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• v.20 no.3
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• pp.131-137
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• 2010

This study was designed to evaluate clinical effects of device for correcting bowleg and Chuna to patients with genu varum. The clinical study was carried out 4 cases with genu varum, who had been treated from April, 2009 to May, 2010 in the department of oriental rehabilitation medicine, Sang-ji university oriental medical hospital. After treating device for correcting bowleg and Chuna, we find out that genu varum was improved after treatment. So these results suggest that device for correcting bowleg and Chuna was effective to patients with genu varum.

• Journal of Society of Preventive Korean Medicine
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• v.28 no.1
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• Korean Journal of Oriental Medicine
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• v.13 no.2 s.20
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• pp.91-100
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• 2007

In this paper, We tried to analyze the patent trend on constitution diagnosis and treatment related technologies. For this, constitution diagnosis and treatment related technologies divided into 16 sub-technology by the advisory committee. And we analyzed patents applied in Korea, Japan, U.S.A., China, and Europe. The 16 sub-technology consist of pulse analyzer, skin diagnosis, tongue analyzer, face and body detector, face analyzer, voice analyzer, intelligence ontology, meridian diagnosis, infrared thermography, electric stimulation, laser, high and low frequency, physical, magnetic, and ultrasound therapy. As a result we found that patents of constitution diagnosis and treatment in Korea has been growing steadily in both quality and quantity since 1980s. The number of patent the pulse analyzer and low frequency therapy are larger than others. But applied relevant international patents, marketability of the patent and Cites per Patent (CPP) index are shown to be very low. In conclusion, to occupy key original technologies of the Oriental medical device, we need to apply more patent of the whole related technology and international patents.

• 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 Journal of Korean Medicine
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• v.35 no.3
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• pp.103-115
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• 2014

Objectives: The purpose of this survey was to investigate the need for new medical devices based on opinions of members of the Korean medical society. Methods: We distributed two independent questionnaires sequentially over two-week intervals to 16,510 doctors via the Korean Medical Society, and received replies from 888 and 928 doctors, respectively. The survey was carried out through a web-based questionnaire system. The first questionnaire focused on demand for new diagnostic and therapeutic medical devices that are specific for Korean medicine (KM). In contrast, the second questionnaire focused on demand for new hybrid medical devices which are useful both in Western medicine (WM) and KM. Results: In purchase intention of Korean medical devices (KMDs), demand for diagnostic devices was greater than for therapeutic ones. Among diagnostic devices, the purchase intention of 'imaging devices' ranked the highest and was followed by 'musculoskeletal diagnostic devices'. Among therapeutic KMDs, the purchase intention of 'musculoskeletal treatment devices' ranked the highest, followed by 'cranial nerve rehabilitation devices'. In the purchase intention of hybrid medical devices that can be used both in WM and KM, 'ultrasonic-based medical device' ranked the highest, followed by 'MRI-based medical device'. Conclusions: There is increasing demand for clinically useful medical devices among Korean medical doctors. Within demand for new devices, hybrid devices that can be used in both WM and KM were most strongly desired. This survey will be useful in establishing strategic plans for the development of medical devices in KM. Keywords: Korean medicine, medical device, demand survey, questionnaire.

• The Journal of Korean Medicine
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• v.32 no.2
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• pp.79-91
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• 2011

Objectives: The purpose was to study the market of traditional Korean medical devices and survey, list and number medical devices in traditional Korean medical clinics. Methods: we researched in three ways. 1. We investigated the list of devices regarded as traditional Korean medical devices in 'Report on production, export, and import of medical devices.' 2. We investigated the statistics of medical devices equipped in traditional Korean medical clinics through the website of the Health Insurance Review & Assessment Service. 3. We surveyed medical devices in traditional Korean medical clinics by mail. Results: 1. We could not directly investigate the market for traditional Korean medical devices because they were not categorized as such ('traditional Korean medical devices'). 2. The number of medical devices in traditional Korean medical clinics has increased alongside the increase of traditional Korean medical clinics. 3. Traditional Korean medical clinics hold over 64,962 medical devices and have below 50 percent of traditional Korean medical diagnosis devices. 4. Meridian function testing machines, pulse diagnosis devices, and yangdorak showed ranking of equipment-ratio equal to ranking of insurance fees. Conclusions: Traditional Korean medical device regulations should be enacted following definitive and concrete Korean traditional medical concepts by the Korean traditional medical society.

• The Korean Society of Law and Medicine
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• v.24 no.1
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• pp.3-42
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• 2023

The Supreme Court en banc decision on December 12, 2022 (docket number 2016Do21314) ruled that the diagnosis of endometrial hyperplasia by an oriental medical doctor using a diagnostic ultrasound device was not an unlicensed medical practice for an oriental medical doctor, which shall be scrutinized by the article 27 (1) of the Korean Medical Service Act. This ruling did not determine that a specific medical practice, especially diagnosis, based on the radiology, which is a part of western medicine, was not an unlicensed medical practice for an oriental medical doctor. Rather, it intended to clarify that the prosecutor should specify and prove the way of diagnosis and he should not prosecute mere the use of a diagnostic ultrasound device itself. To that extent, the ruling is agreeable because, as the oriental medicine community has argued, there is no regulation prohibiting the use of certain devices. It is probable, however, that the way of diagnosis established in radiology, which is a part of western medicine, was actually used in the case. In that case, there is undeniably an unlicensed medical practice for an oriental medical doctor. While many of the cases where the demarcation between (western) medicine and oriental medicine have been problematized thus far have been experimental treatment in nature, the above practice of using ultrasound appears to be frequently done in many oriental clinics, and so it is necessary to cope with the possibility of a disguised unlicensed medical practice. Another problem is the prevention of unfair practice or the protection of medical consumers. In fact, many oriental medical clinics' practice appear to have a tendency of inducing medical consumers' misunderstanding that a diagnosis based on radiology, which is a part of western medicine, were provided. It is hard to respond to this problem with demarcation between (western) medicine and oriental medicine. A new regulation against unfair practice might be necessary to implement.

• Proceedings of the Korean Magnestics Society Conference
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• 2009.12a
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• pp.229-230
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• 2009