• 무역상무연구
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• 제75권
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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.

• 대한예방한의학회지
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• 제14권1호
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• pp.137-149
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• 2010

In recent decades, as the utilization of complementary and alternative medicine in the United State have been growing rapidly, regulatory controls surrounding complementary and alternative medicine(CAM) aims to ensure patient protection against unproven practices and to provide safe and effective treatments. Regulation and policy method on licensing CAM practitioners varies across the states. Over 85% of the states have the licensing system for acupuncturists, chiropractors, and naturopaths. For acupuncture, although the requirements for formal education are various across the states, a unified written examination has been adopted by almost entire states which have acupuncturist licensing law. Medicare, the public medical insurance, does not cover CAM practices except chiropractic and biofeedback. In some states, however, Medicaid programs cover some CAM therapies including acupuncture, naturopathy, and massage therapy. 67% of Health Maintenance Organizations, the private health plans, provide at least one modality of CAM services. In conclusion, government policies have been strengthened to ensure patient protection, and will continue to integrate CAM practices that are proven to be safe and effective into mainstream health care system.

• 동의생리병리학회지
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• 제28권1호
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• pp.9-15
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• 2014

Recently, interest in traditional medicine has increased steadily. Nations having traditional medicine system have been attempting to change it institutionally for the purpose of public application boost in use of traditional medicine. But there are not too many countries which have established the modern system of education and licensing system for traditional medicine with it maintained as a part of a national health care system. The best known examples of nations utilizing traditional medicine are the People's Republic of China, Republic of Korea, Japan, and Taiwan. These countries follow different patterns in the relationship with western medicine according to different social and historical backgrounds. Taiwan has dual medical system as Korean. In this study, we looked through history and the current state of affairs of national health care system in Taiwan, and also found out the licensing system, the educational system, and the curriculum in several universities. thoroughly. Furthermore, we looked into the direction of the policy of Taiwanese health care system which has been becoming an integrated medical system between traditional Chinese medicine and western medicine. With findings based on this study, we deduced implications of a future policy line about the integrated medical system in Korea to minimize conflicts between the concerned parties.

• 대한통합의학회지
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• 제10권3호
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• pp.107-117
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• 2022

Purpose : The purpose of this study was to establish a model of the predictive factors for success or failure of examinees undertaking the Korean physical therapist licensing examination (KPTLE). Additionally, we assessed the pass/fail cut-off point. Methods : We analyzed the results of 10,881 examinees who undertook the KPTLE, using data provided by the Korea Health Personnel Licensing Examination Institute. The target variable was the test result (pass or fail), and the input variables were: sex, age, test subject, and total score. Frequency analysis, chi-square test, descriptive statistics, independent t-test, correlation analysis, binary logistic regression, and receiver operating characteristic (ROC) curve analyses were performed on the data. Results : Sex and age were not significant predictors of attaining a pass (p>.05). The test subjects with the highest probability of passing were, in order, medical regulation (MR) (Odds ratio (OR)=2.91, p<.001), foundations of physical therapy (FPT) (OR=2.86, p<.001), diagnosis and evaluation for physical therapy (DEPT) (OR=2.74, p<.001), physical therapy intervention (PTI) (OR=2.66, p<.001), and practical examination (PE) (OR=1.24, p<.001). The cut-off points for each subject were: FPT, 32.50; DEPT, 29.50; PTI, 44.50; MR, 14.50; and PE, 50.50. The total score (TS) was 164.50. The sensitivity, specificity, and the classification accuracy of the prediction model was 99 %, 98 %, and 99 %, respectively, indicating high accuracy. Area under the curve (AUC) values for each subject were: FPT, .958; DEPT, .968; PTI, .984; MR, .885; PE, .962; and TS, .998, indicating a high degree of fit. Conclusion : In our study, the predictive factors for passing KPTLE were identified, and the optimal cut-off point was calculated for each subject. Logistic regression was adequate to explain the predictive model. These results will provide universities and examinees with useful information for predicting their success or failure in the KPTLE.

• 대한치과의사협회지
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• 제56권9호
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• pp.479-490
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• 2018

3D printing technology supporting the specific patient medical services is actively being implemented in dentistry. The purpose of this study is to introduce the legal and institutional considerations to the medical practitioners in dentistry who must observe when they manufacture medical devices using 3D printers, and to provide a ways to activate and enhance their utilization in the domestic approval point of view for medical devices. Through the public data of government agencies and related organizations, the statutory system and compliance matters related to the manufacture of 3D printing medical devices have been examined and reviewed for the government's improvement efforts. Through the study, the government has been actively improving the system and making policy, but the active interest and participation of medical professionals and related workers are continually required to solve the problems which are scattered. 3D printing technology is expected to be more frequently utilized in the field of dentistry in near future. Therefore, it is essential to establish measures to improve the regulation through continuous cooperation with the related ministries with the long-term point of view enhancing smooth entry to the market for the medical devices by taking data from the continued research.

• 한국임상수의학회지
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• 제35권1호
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• pp.1-6
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• 2018

This study reviewed the regulatory safety management system for prevention of side effects of veterinary medical devices in Korea based on data obtained through analyses of those medical devices. In order to ensure the safety of medical devices, Ministry of Food and Drug Safety has established the management system include licensing, test inspection (134 designated clinical trial agencies) and post management. In addition, it was introduce the good manufacture practice (GMP) certification system and device tracking requirements. In contrast, it is necessary to establish regulations for side effects report and awareness on veterinary medical devices in Korea. The center for veterinary medicine of FDA in the United States has been operated side effects reporting system of veterinary medical devices from user, manufactures and distributor. Due to increase the use of various kinds of veterinary medical devices for animals, it should be required to improve regulation related to the licensing procedures, GMP system, and the side effects reporting system in our country.

• 기술혁신연구
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• 제28권4호
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• pp.1-26
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• 2020

전 세계적인 코로나19의 확산으로 인해, 진단시약 등과 같은 감염병 의료 및 의료기기 신제품이 비약적으로 개발·출시되고 있으며, 이의 빠른 수급을 위해 각 국가들은 수입규제를 완화하거나 신속한 인·허가를 위한 정책을 펼치고 있다(NIDS, 2020). 반면, 신종 감염병과 관련 없는 신개발 의료기기의 경우 오히려 시험검사 등 지연 및 취소되는 사례가 발생하고 있는 등 여전히 엄격한 인·허가규제를 통해 시장에 진출하고 있다. 이에 본 연구는 의료기기신제품이 시장에 진출하면서 마주하게 되는 정부소관법률에 특화하여 규제강도 영향요인을 도출하고 규제강도를 분석하여 규제대응 프레임워크를 제안하였다. 연구방법은 문헌연구, Failure Mode and Effects Analysis(FMEA)기법 적용, 전문가인터뷰(1차):아이디어수집, 전문가인터뷰(2차) : 타당성검증의 방법으로 진행하였으며, FMEA기법의 적용프로세스를 통해 우선 규제단계별 영향요인의 발생영향도와 규제사무 유형별 부담영향도를 곱하여 규제요인의 중요도를 구하고, 규제영향 심각도를 곱하는 방식으로 규제강도 정량화방법을 제시하였다. 시사점은 최근 해외 주요 국가들 및 우리나라 정부가 코로나19에 따른 신개발의료기기의 신속한 인·허가를 위한 특별규제정책 및 완화정책을 펼치며 적극적으로 대응하고 있는 시점에 본 연구에서 제안된 프레임워크를 통해 향후 기존 의료기기 신제품의 인·허가 정책 규제프로세스에도 보다 적극적이며 선제적인 대응이 될 수 있도록 규제의 개선방향과 규제대응 방안이 이루어지길 기대한다.

• 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.

• 보건행정학회지
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• 제29권4호
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• pp.394-398
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• 2019

Education on the physician continues with undergraduate medical education, graduate medical education, and continuous medical education. The countries such as the United States, Japan, the United Kingdom, German, and others are required to undergo training in the clinical field for 2 years after completing the national medical examination, and to become doctors after passing the clinical practice license test. Korea can obtain a medical license and become a clinical doctor at the same time if it passes written and practical tests after completing 6 years of undergraduate medical education or 4 years of graduate school. About 90% of medical school graduates replace clinical practice with 4-5 years of training to acquire professional qualifications, but this is an option for individual doctors rather than an extension of the licensing system under law. The medical professional qualification system is implemented by the Ministry of Health and Welfare on the regulation. In fact, under the supervision of the government, the Korean Hospital Association, the Korean Medical Association, and the Korean Academy of Medical Sciences progress most procedures. After training and becoming a specialist, the only thing that is given to a specialist is the right to mark him or her as a specialist in marking a medical institution and advertising. The government's guidelines for professional training are too restrictive, such as the recruitment method of residents, annual training courses of residents, dispatch rule of the residents, and the quota of residents of training hospitals. Although professional training systems are operated in the United States, the United Kingdom, France, and Germany, most of them are organized and operated by public professional organizations and widely recognize the autonomy of academic institutions and hospitals. Korea should also introduce a compulsory education system after graduating from medical education and organize and initiate by autonomic public professional organization that meets global standards.

• Journal of Acupuncture Research
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• 제32권4호
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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.