• 대한한의학회지
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• 제32권2호
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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.

• 대한한의학회지
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• 제34권1호
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• pp.69-79
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• 2013

Objectives: The aim of this survey was to investigate utilization, intended use, problems with and demand for medical devices by surveying members of the traditional Korean medical society. Methods: We distributed questionnaires to 13,957 traditional Korean medical doctors via e-mail, and received replies from 1,225. The questionnaire consisted of 4 multiple-choice questions for survey respondent information, 8 multiple-choice questions about the status of medical devices utilizing, and a short answer question about the demand for medical devices. Results: Use of medical devices in traditional Korean medical clinics is common. Diagnostic medical devices are mainly used to assess the patient's condition and to establish a close rapport with clients. In case of therapeutic medical devices, they are usually used for secondary treatment. Issues with traditional Korean medical devices currently in use were ineligibility for national health insurance, low reliability, uncertain validity, and high price. In development of traditional Korean medical equipment, the need for diagnostic medical devices was greater than for therapeutic, and the need for the recording and analysis of medical image data and visualization of medical information was great. Conclusions: There is growing demand for facilitating the development and commercialization of traditional Korean medical devices. To satisfy this demand, research on evaluation indicators that reflect functional and structural clinical information and how to clinically assess the indicators should proceed.

• 대한한의학회지
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• 제35권3호
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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.

• 대한의용생체공학회:의공학회지
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• 제31권2호
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• pp.123-128
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• 2010

The thermometers is widely used in diagnostic medical devices, and the safety and accurate performance of these devices are important in the diagnosis and monitoring of personal health. Especially, the accuracy of infra-red thermometer is highly emphasized. Here two typical thermometers are utilized for this purpose: the electronic thermometers measure body temperature by contacting to subject while infra-red thermometers measure by no contacting to subject. Therefore, the evaluating items of each thermometer are different, and the standard for each temperature is highly needed. But, there have been no international standards of each thermometer such as IEC. In this paper, we developed the standards of electronic and infra-red thermometer based on national standards such as KS, ASTM, EN, JIS and FDA guidance. The new standards focused on the safety and suitable performance for health care. This standards were applied to enact and revise the electronic medical device standards. So it can be applied to evaluate the safety and performance on technical file review. We predict that this standard will improve the quality of diagnostic medical devices (thermometers) and increase the international competitive power of domestic product.

• 대한수의학회지
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• 제57권2호
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• pp.71-78
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• 2017

Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.

• 전자공학회논문지SC
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• 제49권2호
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• pp.55-62
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• 2012

정보기술과 의료기기의 융합에 의해 혈당을 집에서 측정하거나 운동 시에 심박수를 측정하는 것과 같이 건강관련 정보를 언제 어디서나 측정할 수 있게 되었고, 이에 따라 의료를 장소에 구애받지 않고 쉽게 접근할 수 있게 되었다. 최근에 유헬스케어 의료기기 시장이 빠르게 성장하고 있으나 이러한 기기의 안전성과 유효성을 평가하는 가이드라인이 아직 마련되지 않은 실정이다. 이를 위해 식약청, ISO/IEEE, CE 등 국내외의 유헬스케어 관련 규정을 조사하고, 이 중 유헬스케어 의료기기에 관련된 안정성 및 성능 평가에 대한 시험 방법과 항목을 제안하였다. 유헬스케어 의료기기의 가장 큰 특성인 무선 데이터 통신에 있어 데이터 무결성과 기기 사용환경이 다양하기 때문에 환경 요인이 기기에 미치는 영향을 평가하였다. 이를 바탕으로 휴대형 유헬스케어 의료기기의 평가 가이드라인을 제안하였다. 제안하는 지침을 기반으로 휴대형 유헬스케어 기기를 개발한다면 사용자들에게 보다 안전성과 신뢰도 높은 기기를 제공할 수 있을 것으로 기대된다.

• 대한예방한의학회지
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• 제28권1호
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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.

• 대한수의학회지
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• 제55권2호
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• pp.97-103
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• 2015

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

• 대한의용생체공학회:의공학회지
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• 제29권6호
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• pp.415-430
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• 2008

The technologies in medical electronic implant(MEI) devices are developing rapidly, and already, there are various kinds of the MEI devices in the current medical equipments market. Recently, the global market scale of MEI devices have been increased about 13% year by year, and the import amount of MEI devices in Korea is increasing rapidly. In the near future, the demands of MEI devices will be magnificently increasing by the continuous development of the biomedical electronics devices which coupled with neural, brain and other organs will bring us to tremendous effects, such as providing new therapeutic solutions to patients, extension and saving human life, and an important clue of medical development. However, the investment of the research and the activity of developments in this field are still very weak in the Korea. Consequently, this paper introduces about the research trends of MEI devices, and technological problems those must be solved, and then concludes with the suggestions in order to be the leading country in this field.

• 대한의용생체공학회:의공학회지
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• 제39권6호
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• pp.268-277
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• 2018

With drastic change in the market and technology of medical devices, a comparative analysis is necessary in advanced systems internationally in order to prepare domestically applicable plans for improvement in classification and differential grade management for items of medical devices. This research examines and analyzes the differences of definition and legal systems of medical devices among Korea, United States, EU, Japan and China, and investigates classification and grading system of each country to identify disadvantages of classification and grading structures for medical device in Korea. This research suggests ways to supplement the disadvantages of domestic classification and grading system of medical devices, and elicits differential management plans for medical devices.