• Journal of Technology Innovation
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• v.8 no.2
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• pp.1-17
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• 2000

Recently, due to the primary emphasis of health industry and to the restriction of budget, setting the priorities for effective and efficient investment on the medical device and material products has been one of the critical issues in the government sector. This paper shows how an Analytic Hierarchy Process (AHP) model can be used for assessing selected medical device and material products for grant of the Ministry of Health & Welfare. The final results show that unabsorbable suture is the most attractive medical device product among 88 evaluated products, followed by IV cannula, central venous catheter.

• Journal of Environmental Health Sciences
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• v.5 no.1
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• pp.1-9
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• 1978

Biological safety, physico-chemical and microbiological experiments were carried out in order to study the possibility of radiation sterilization on medical products, such as polyethylene and polystyrene bottles, gauze sponges and surgical silk suture. Results are as follows: 1. Biological test on plastic samples as to acute systemic toxicity, eye irritation, skin irritation, pyrogen, haemolysis showed satisfactory results. But physico-chemically, the oxidizable matter, nonvolatile residues, residue on ignition seemed to be increased slightly in irradiated samples, though the experimental results were within the range of U.S.P. 19, N.F. and K.P. III. 2. After irradiation, both plastic and gauze sponges showed considerable decrease in pH. 3. Most medical products were sterilized by 1.5 Mard. For the sterilization of the suigical silk suture, 4.5 Mrad is required dul to its radiation resistant micro-organisms. 4. Biologically, total dose of 2.5 Mrad was safe enough to sterilize the medical products, and physico-chemically the results are acceptable according to U.S.P. 19 and K.P. III. However, better results may be expected when the quality of material and additives are improved.

• Journal of Korean Medical classics
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• v.27 no.4
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• pp.181-198
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• 2014

Objectives : This study was to analyze definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Regarding the current laws and regulations that are relevant to herbal medicinal preparations, we should 1) clarify the boundaries between the duty of physicians and that of pharmacists, 2) limit the principles of Korean Medicine as well as the contents of the related textbooks, 3) find a way to protect the intellectual property rights for herbal medicinal preparations, and 4) establish a separate standard for drug classification regarding herbal medicinal preparations. In case of crude drug preparations, we should 1) clarify the meaning and limitations of the phrase, "the point of view of Western medicine," and 2) establish a classification standard for drugs that are used in Korean Medicine and clarify the boundaries between herbal drug preparations and crude drug preparations. Furthermore, laws and regulations apropos of new drugs from natural products do not actually fit the concept of "new drug," and due to subordinate laws, a supplement to a new drug submission is contradictorily misclassified as a new drug from natural products. Conclusions : The problems of legal definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products have emerged in the process of giving approval to drugs that are made of herbs and natural products under the dualistic medical and pharmaceutical System. Laws and regulations that differentiate the process of approving herbs that are used in Korean Medicine and the others should be established.

• Journal of Veterinary Clinics
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• v.39 no.1
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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.

• Journal of Preventive Medicine and Public Health
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• v.14 no.1
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• pp.97-110
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• 1981

This study was conducted in order to investigate the status of harmful working environ ment on twelve rubber and ten chemical products manufacturing industries in Busan area over a period of five months from lune 1 to October 31, 1980. The summarized results were as follows: 1. The highest and lowest mean values of harmful environmental elements in workroom of rubber products manufacturing industries were noted in twisting (98.7dB) and coating department (77.3dB) to noise, molding ($6.43mg/m^3$) and forming ($1.33mg/m^3$) to dust, bonding (toluene 463.7ppm, xylene 457.8ppm and benzene 111.8ppm, respectively) and splicing (toluene 90.0ppm, xylene 83.3ppm and benzene 6.7ppm, respectively) to organic solvents, respectively. Also in chemical products manufacturing, they were noted in grinding (95.1dB) and shining department (76.8dB) to noise, packing ($4.30mg/m^3$) and staining ($3.20mg/m^3$) to dust, shining (393.3ppm and 375.0ppm, respectively) and varnishing(125.5ppm and 121.7ppm, respectively) to toluene and xylene, and scattering (51.8ppm) and mixing (23.9ppm) to benzene, respectively. 2. The mean values of harmful elements in workroom of rubber products manufacturing were 86.3dB to noise, $4.16mg/m^3$ to dust, 258.2ppm to toluene, 230.3ppm to xylene, and 5 4.0ppm to benzene, respectively. Also in chemical products manufacturing, they were 85.2dB to noise, $3.69mg/m^3$ to dust, 227.9ppm to toluene, 213.2ppm to xylene, and 36.3ppm to benzene, respectively. 3. Number of workers exposed to harmful working environment, over TLV, of a total 10,195 workers in rubber products manufacturing were 1,002(9.8%) to noise, 212 (2.1%) to dust, 1,581(15.5%) to toluene, 1,509(14,8%) to xylene, and 1,524(15.0%) to benzene, respectively. Number of workers exposed to harmful working environment, over TLV, of a 1,913 workers in chemical products manufacturing were 112(5.9%) to noise, 132(6.9%) to each organic solvent, respectively. 4. The values of noise and dust of rubber and chemical products manufacturing in 1980 were lower then those in 1977, but the value of organic solvent in 1980 was similar with that in 1977.

• Journal of Korean Medical classics
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• v.27 no.2
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• pp.77-95
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• 2014

Objectives : This study was to analyze the definitions of herbs, herbal drugs, crude drugs and natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbs, herbal drugs, crude drugs and natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Herbs are defined as "refined things that are cut and dried in their most original state". The definition of crude drugs includes herbs and the "cell contents, secretion, extracts, minerals and other parts of animals and plants that are used medicinally". The concept of natural products is expanded to adding tissue cultures to the definition of crude drugs. Conclusions : The definition of herbs should at least include all products that are "processed, extracted and prepared" as well as contents that consist of various forms of hospital-prepared herbs. The term "herbal drug" corresponds to a traditional term of "drug", and this should be established as a concept to explain "drugs in raw materials that are used to prepare herbs and/or manufacture herbal medicine". The legal definition of herbs should include the concept of crude drugs. Herbal drug preparations and crude drugs should be included in the definition of herbal drugs.

• Bulletin of the Korean Chemical Society
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• v.31 no.7
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• pp.2051-2053
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• 2010

• Journal of Veterinary Clinics
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• v.32 no.1
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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.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.41-52
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• 2023

With the international change in the medical device market owing to the development of innovative medical engineering and the use of various raw materials, a systematic and rational medical device classification system is needed to safely manage newly developed medical devices. This study aims to improve the domestic medical device classification system by proposing product establishment and segmentation. It is based on medical device products from the United States and Europe that are only available in foreign systems and are more subdivided than domestic products. This study analyzes and compares the domestic and foreign medical device classification systems by examining laws, guidelines, and analysis reports in Korea, the United States, and Europe. In accordance with product establishment and segmentation criteria, products subject to improvement are presented. This study contributes to safely managing medical devices that do not fit with the current classification system and to solving the confusion caused by the lack of international harmony in product classification systems.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.73-79
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• 2023

The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.