• Journal of Biomedical Engineering Research
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• v.45 no.4
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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.

• Korean Journal of Veterinary Research
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• v.55 no.2
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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.

• Journal of Veterinary Clinics
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• v.35 no.4
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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.

• Health Policy and Management
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• v.33 no.2
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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.

• Korean Journal of Veterinary Research
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• v.57 no.2
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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.

• The Journal of the Convergence on Culture Technology
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• v.8 no.5
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• pp.1-7
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• 2022

Korean medical device industry has laid the foundation for full-fledged growth and development with the G7 medical engineering technology development project that started in 1995, and the medical device production in 2020 increased by 8.52 times and the export by 13.94 times, compared to those in 2001. In early years, electronic medical devices such as ultrasound imaging device contributed greatly to Korean medical industry, but top ranks in medical device production and export in Korea has shifted recently to in vitro diagnostic medical devices and dental implants. However, the share of imported medical devices in the Korean medical device market have not changed much; it still ranges in 60 to 70%, as the Korean medical device industry produces and exports mid- to low-priced medical devices, and technology-intensive and capital-intensive high-priced medical devices are mainly imported. In this paper, we compare the leading medical devices produced by major Korean companies and those by global top medical device companies to suggest strategies for the Korean medical device companies to enter the global market.

• The Korean Society of Law and Medicine
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• v.9 no.2
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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.

• Journal of Veterinary Clinics
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• v.36 no.1
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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.

• The Journal of the Convergence on Culture Technology
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• v.10 no.6
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• pp.309-314
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• 2024

The medical device industry is changing rapidly by applying the latest scientific and technological advancements. In particular, with the development of biotechnology, the proportion of in vitro diagnostic medical devices that diagnose diseases by analyzing body fluids such as blood and implant medical devices that can replace the role of human tissues and organs has recently increased rapidly In order to educate and supply manpower in the newly changing medical device industry, the development of a new practical training course is necessary. In this paper, we develop and report a hands-on training course using nitinol stents and a model stent introducer. The model stent introducer for this practical training can be easily made using raw materials used by the manufacturer, and the stents used in the training were provided by the stent manufacturing company. Through this practicum, students can experience part of the work of an actual medical device company and understand engineering theories applied to medical devices through practicum. In order for the Korean medical device industry to become a global leader, it is necessary to develop practical training courses through close cooperation between universities and industry.

• KIPS Transactions on Computer and Communication Systems
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• v.12 no.2
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• pp.77-84
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• 2023

Dengue virus transmission is a viral infection disease between humans and Aedes mosquitoes. Dengue is ubiquitous throughout the tropics and subtropical zones, where 1/3 of the global population live. The weather in Korea is also changing to subtropical weather, resulting in increased vulnerable Korean population to dengue virus transmission. It is important to control and prevent the dengue risk with track-recording & monitoring system. It is also required to have the control system to treat and monitor dengue patients with various cases such as regions, ages, genders according to the track-record of the disease. In this paper, we developed a Dengue Control & Prevention System, which can monitor and control dengue outbreaks in real-time with in-vitro diagnostic devices. Dengue Control & Prevention System is composed of in-vitro diagnostic device, which is a fluorescent immunoassay, and real-time monitoring system. In the future, we expect that our Dengue Control & Prevention System can be upgraded to have various disease information from Korea Disease Control and Prevention Agency for government policies and diseases control in Korea.