• 대한의용생체공학회:의공학회지
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• 제45권4호
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• pp.148-161
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• 2024

This study compares and analyzes domestic and international regulations on the application of software in In Vitro Diagnostic (IVD) medical devices, proposing improvements for South Korea. The research examines regulatory statuses in Europe, the United States, and Australia, identifying differences in regulatory approaches and definitions. Despite varying methods, all countries recognize the importance of software, though the regulatory scope differs. Considering the current domestic regulations, systematic improvements are essential for sustainable growth. This study suggests regulatory enhancements and draft guidelines, emphasizing the need for ongoing monitoring and stakeholder input to develop practical solutions.

• 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.

• 한국임상수의학회지
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• 제35권4호
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• pp.119-125
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• 2018

In vitro diagnostic veterinary medical reagents (IVDVMRs) were diverted the medical devices from medicine by the revision of the pharmaceutical affairs act enforcement regulations in 2015 in Korea. It classified into class I-IV according to risks of individual and public health. However, good manufacturing practices requirements on IVDVMRs were exempted from the current system. The registration of IVDVMRs by the Animal and Plant Quarantine Agency has gradually increased since 2012, and total of 584 products from 68 companies were registered from 1978 to 2017. Most of these items are clinical immunochemistry (infection disease), clinical immunochemistry (non-infection disease), molecular genetics, endocrinology, blood gas analysis, clinical microbiology, toxin, heavy metal and drug of abuse, other etc. The market size of IVDVMRs reported from the Korea Animal Health Products Association was estimated to be approximately 51.9 billion won in 2017. The domestic consumption and the export sales were approximately 31.2 and 20.7 billion won, respectively. They are increasing 23.9% (CAGR) in domestic consumption and 40.4% (CAGR) in export from 2011 to 2017.

• 보건행정학회지
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• 제33권2호
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• pp.173-184
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• 2023

Background: The coronavirus disease 2019 pandemic has been challenging the healthcare service, i.e., the vitalization of the point of care accompanying self-testing in vitro diagnostic medical devices (IVDs). This study aims to suggest priority criteria to classify self-testing IVDs using the analytic hierarchy process technique. Methods: Two dimensions of the characteristics embedded in the IVDs and the diseases to be diagnosed with self-testing IVDs were parallelly considered and independently investigated. In addition, three expert panels consisting of laboratory medical doctors (n=11), clinicians (n=10), and citizens (n=11) who have an interest in the selection of self-testing IVDs were asked to answer to questionnaires. Priorities were derived and compared among each expert panel. Results: First of all, ease of specimen collection (0.241), urgency of the situation (0.224), and simplicity of device operation (0.214) were found to be the most important criteria in light of the functional characteristics of self-testing IVDs. Medical doctors valued the ease of specimen collection, but the citizen's panel valued self-management of the disease more. Second, considering the characteristics of the diseases, the priority criteria were shown in the order of prevalence of diseases (0.421), fatality of disease (0.378), and disease with stigma (0.201). Third, medical doctors responded that self-testing IVDs were more than twice as suitable for non-communicable diseases as compared to communicable diseases (0.688 vs. 0.312), but the citizen's group responded that self-testing IVDs were slightly more suitable for infectious diseases (0.511 vs. 0.489). Conclusion: Our findings suggested that self-testing IVDs could be primarily classified as the items for diagnosis of non-communicable diseases for the purpose of self-management with easy specimen collection and simple operation of devices, taking into account the urgency of the situation as well as prevalence and fatality of the disease.

• 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.

• 문화기술의 융합
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• 제8권5호
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• pp.1-7
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• 2022

한국의 의료기기 산업은 1995년부터 시작된 G7 의료공학기술개발사업으로 본격적인 성장과 발전의 기틀을 마련하였으며 2020년 한국 의료기기 생산실적은 2001년에 비하여 8.52배, 수출 실적은 13.94배 성장하였다. 의료기기 국산화 개발 초기에 초음파 의료기기 등 전자 의료기기의 개발이 활발하였던 것과 비교하여 2020년에는 체외진단시약과 치과용 임플랜트의 생산 및 수출 실적이 상위권을 차지하고 있다. 그러나 한국 의료기기 시장에서 수입 의료기기가 차지하는 비중은 60-70%에서 큰 변화가 없는데 이는 한국의 의료기기 산업이 중저가 의료기기를 생산 수출하고, 기술집약적이고 자본집약적인 고가 의료기기는 주로 수입에 의존하고 있기 때문이다. 본 논문에서는 한국과 세계시장의 주요 의료기기 회사들의 생산 품목을 비교하여 한국 의료기기 산업의 세계 시장 진출에 대한 전략을 제시하고자 한다.

• 의료법학
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• 제9권2호
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• pp.209-229
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• 2008

When we are totalizing the lawsrelated to the medical, as the Laboratory medical testing is a kind of the medical act, it is the regulation that the medical technologist can analyze the specimen using in vitro diagnostic devices and diagnosticdrugs under the guidance of doctor or dentist from a corresponding medical institution and can report through verification and interpretation. However, in real medical fields, 'the guidance of doctor' is seriously in-sufficient or even the person who is not the medical technologist is executing. Furthermore the cases that produce inspection results with devices or reagents which are not validated nor approved have been frequently occurred. The result of Laboratory medical testing derived from this procedure can become the important information for the disease control of a country, and also can be decisive to the definite diagnosis and the prognostic monitoring about the patient disease. In spite of its significant medical act to be applicable to an unique proof with the related expert appraisal result in the medical mal-practice lawsuit, our reality in which the quality control is not properly working due by the costs and the labor shortage related to the Laboratory medical testing is quietly in bad condition. Even from now, the government should recognize the significance of the Laboratory medical testing and must achieve more strict administrative management as well as the law maintenance.

• 한국임상수의학회지
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• 제36권1호
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• pp.1-6
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• 2019

This study reviewed the trends and prospect of the market for veterinary medical devices in Korea. The registration of veterinary medical devices has sharply increased since 2013, and a total of 2,133 products from 348 companies were registered by 2018. Of these products, the proportion of the instrument, in vitro diagnostic (IVD) reagents, medical only used for animal and supplies were 51.6%, 35.7%, 7.6% and 5.1%, respectively. The sales amount of veterinary medical devices is approximately 95.8 billion won in 2017. The sales of domestic consumption and imports were 53.9 and 41.9 billion won, respectively. They are increasing 14.9% (CAGR) in the domestic consumption, and 44.0% (CAGR) in the export from 2011 to 2017, respectively. The proportion of IVD reagents, instrument, medical only used for animal and supplies were 54.2%, 41.0%, 3.8%, and 1.0%, respectively. The top 10 items with high sales were IVD reagents for clinical immunochemistry, visceral function testing instrument, hematological testing apparatus, syringes, IVD reagents for molecular genetics, etc. They are widely used from 3,926 animal hospitals in 2017. This study suggested that registration and sales of veterinary medical devices have gradually increased since 2013 as the demand of health care services for various animals. Therefore, the veterinary medical devices industry is expected to grow in the future.

• 문화기술의 융합
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• 제10권6호
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• pp.309-314
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• 2024

의료기기 산업은 최신 과학 기술 발전을 적용하며 급속하게 변화하고 있다. 특히, 생명공학의 발달로 혈액 등 체액을 분석하여 질병을 진단하는 체외진단 의료기기와 인체 조직 및 장기의 역할을 대체할 수 있는 임플란트 의료기기의 비중이 최근 급격히 증가하였다. 새롭게 변화하는 의료기기 산업분야의 인력을 교육하여 공급하기 위해서는 새로운 실습 교육 과정의 개발이 필요하다. 우리는 본 논문에서 니티놀 스텐트와 모형 스텐트 삽입기를 이용한 실습 교육 과정을 개발하여 보고한다. 이 실습 교육의 모형 삽입기는 제조회사에서 사용하는 원자재를 이용하여 쉽게 만들 수 있으며 실습에 사용하는 스텐트들은 의료기기 회사에서 제공하였다. 이 실습을 통하여 학생들은 실제 의료기기 회사 업무의 일부를 경험할 수 있고, 의료기기에 적용되는 공학적 이론들을 실습을 통하여 이해할 수 있게 된다. 한국 의료기기 산업의 글로벌 선두권 진입을 위해서는 대학과 산업체의 긴밀한 협조를 통한 실습 교육과정 개발이 필요하다.

• 정보처리학회논문지:컴퓨터 및 통신 시스템
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• 제12권2호
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• pp.77-84
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• 2023

뎅기열 발병은 전 세계 인구의 약 1/3이 거주하고 있는 열대, 아열대 기후에 집중되며, 우리나라도 아열대 기후로 바꾸고 있어 뎅기열 발병에 취약해지고 있다. 뎅기열은 감염병 관리 차원에서 진단 이력 관리가 중요하다. 감염병 이력에 따라서 지역별, 연령별, 남녀비율 등에 따라서 개개인의 치료 방법과 전략을 수립할 수 있는 체계가 필요하다. 본 논문에서는 뎅기열 관제시스템을 제안하며, 이러한 시스템은 뎅기열의 발병에 대한 체외진단기기를 이용한 실시간 집계방식으로 발병률과 사망률을 감소시킬 수 있는 전략을 수립하는 데 유용하게 활용될 수 있다. 뎅기열 관리를 위한 관제시스템 구성으로 형광면역진단 키트를 이용한 뎅기열 체외진단기기와 실시간 뎅기열 관제시스템으로 구성되어 있다. 본 논문으로 개발된 뎅기열 관제시스템은 향후 정부의 감염병 통합정보와 결합되어 다양한 감염병 관리 및 정책 활용을 위해서 활용될 수 있을 것이다.