• 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.

• Journal of Veterinary Science
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• 제19권6호
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• pp.846-849
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• 2018

A group of benign Theileria species, which are often referred to as T. orientalis/T. buffeli/T. sergenti group, has low pathogenicity in cattle. Herein, we report on Theileria spp. in cattle on a farm from China. Based on phylogenetic analysis of the major piroplasm surface protein gene sequences, we detected 6 genotypes that were categorized as Types 1, 2, 3, 4, and 5 as well as an additional Type 9 genotype. The new epidemiological features of the T. orientalis/T. buffeli/T. sergenti parasites in China indicate a greater diversity in the genetics of these species than had been previously thought.

• 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.

• 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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• 제32권1호
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• pp.85-90
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• 2015

In this study, we investigated the number of categories of veterinary medical devices registered by Animal and Plant Quarantine Agency (QIA) by 2013. We also analyzed the sales of the veterinary medical devices reported from Korea Animal Health Product Association (KAHPA) from 2011 to 2013. The registration rate of veterinary medical devices has sharply increased since 2008, and a total of 495 categories from 141 companies were registered by the end of 2013. The multi-frequency products registered for companion animals were ultrasound imaging system, x-ray system, microchip & reader, telemetry system transmitter, and hematology analyzer. The veterinary medical devices for farm animals include marker, artificial insemination catheter, injector, and ultrasound imaging system. Of these products, the multi-frequency products dominated on the veterinary medical devices market. The market size of 223 (45.0%) veterinary medical devices was estimated to be approximately 20.6 billion Won in 2013; the proportion of domestic products and imports was 56% to 44%; the proportion of domestic demand and export was 82% to 18%, respectively. This study suggested that the registration and sales of the veterinary medical devices have gradually increased as the demand of health care services got bigger in Korea.

• 대한수의학회지
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• 제54권3호
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• pp.151-157
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• 2014

A nationwide survey on radiation safety management in Korean animal hospitals was conducted. By 2013, 53 radiation generators were registered as veterinary medical devices (41 X-ray generators and 12 computed tomography scanners). Additionally there were six approved laboratories for radiation equipment and protection facility, and five approved laboratories for radiation exposure of employees, respectively. By March 2013, 2,030 out of 3,829 animal hospitals operated radiation-generating devices. Among these devices, 389 (19.2%) out of 2,030 were not labeled with the model name and 746 (36.7%) were not labeled with production dates. Thus, most veterinary X-ray generators were outdated (42.6%) and needed replacements. When periodic inspections of 2,018 animal hospitals were performed after revision of the Veterinarians Act in 2011, the hospitals were found to be equipped with appropriate radiation generators and protection facilities. Among 2,545 employees exposed to radiation at the hospitals, 93.9% were veterinarians, 4.3% were animal nurse technicians, and 18% held other positions. Among 169 employees supervised by administrators, none of those had a weekly maximum operating load that exceeded $10mA{\cdot}min$. This study suggests that the radiation safety management system of animal hospitals was general good.

• 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.

• 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.

• Asian-Australasian Journal of Animal Sciences
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• 제2권3호
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• pp.514-515
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• 1989

• 한국임상수의학회지
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• 제39권1호
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• pp.9-15
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• 2022

As more veterinary clinics become specialized with the growth of the companion animal market, an increasing number of veterinary clinics perform orthopedic surgery and use orthopedic products, some of which are defective and have side effects. Thus, the present study aimed to prepare fundamental data for the revision and development of manufacturing standards for these products in order to prevent their side effects. We conducted a survey targeting veterinary clinics as consumers and medical device companies as suppliers. Veterinary clinics were surveyed via offline and online methods; 320 clinics that offered orthopedic surgery and approximately 4,000 veterinary clinics that were registered in the Korean Veterinary Medical Association were targeted, and 153 veterinary clinics responded to the survey. The survey for medical device companies, was performed online, targeting 29 companies; 14 companies responded. The number of side effects of orthopedic products was higher in animal orthopedic products than in those for human use. Many consumers tended to suspect that side effects were caused by product defects. To resolve side effects after using orthopedic products, consumers mostly underwent reoperation. Meanwhile, some severe cases proceeded to legal disputes. Similarly, medical device companies, or the suppliers, responded that most side effects occurred in veterinary orthopedic products and that product defects and mistakes in use were the causes. As for most of the follow-up actions for side effects, these companies either reported the issue to those in charge or analyzed and resolved the issues themselves. Therefore, to develop quality products, suppliers should be provided with clear standards for the production, and information disclosure and a report system for side effects should be particularly established to gain consumers' trust regarding the safety of these products.