• 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.

• Journal of Technology Innovation
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• v.28 no.4
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• pp.1-26
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• 2020

Due to the spread of Corona 19 around the world, Infectious Disease Medicine and New Medical Devices such as Diagnostic Agent are being rapidly developed and launched, and for the fast supply and demand of these, each country has eased import regulations or has implemented policies for fast approval(NIDS, 2020). On the other hand, New Developed Medical Devices that are not related to New Infectious Diseases, they are still entering the market through strict licensing and licensing regulations, such as delay and cancellation in the test inspection process, etc. Therefore, This Study specialized in the government-managed laws encountered when New Medical Devices enter the market, derive Factors influencing the Strength of Regulations, analyzes the Strength of Regulations, and proposes a Regulatory Response Framework. The Research Method was conducted by Literature Research, was applied by Failure Mode and Effects Analysis(FMEA) Method, Expert Interview(1st): Idea Collection, Expert Interview(2nd): Validation, and Priority through the Application Process of FMEA Method. A Method of Quantifying the Intensity of Regulation was proposed by multiplying the Impact of the Influencing Factors for each stage of regulation and the Burden Impact for each type of Regulatory Affairs to find the Importance of the Regulatory Factors and multiplying the Severity of the Regulatory Impact. The Implications are that major overseas countries and the Korean government are actively responding with Special Regulatory Policies and Mitigation Policies for fast licensing of New Developed Medical Devices in accordance with Corona 19. It is expected that the direction for improvement of regulations and measures to respond to regulations will be implemented so that a more proactive and preemptive response to the regulatory process of the licensing policy for New Devices can be achieved.

• International Commerce and Information Review
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• v.16 no.1
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• pp.207-226
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• 2014

A trade logistic informatization system under Open Systems Interconnection(OSI) includes a Port Management Information System, a Maritime Information System, and an Export and Import Batch Processing System. These have made a great contribution in the creation of more convenient and efficient management for the logistics industries in our country. However, this management is exposed to the technological problems of networks due to the explosive use in the sending and receiving of e-documents. For our country to grow as a center for port and logistic information, we should make the best use of the control systems using networks and further advance the export and import logistic systems. Therefore, this study aims to propose management systems for a composite network and an invasion detection system for efficient management of an e-trade network under OSI. Methods to rationalize the internal organizations such as coordination of organizations and human resources according to alloted network functions, commissions and arbitrary decisions, and reorganization of relevant regulations are not discussed here. This study looked at trade network under OSI from the aspect of practical business affairs and presented a basis for further interpretation.

• Journal of Environmental Health Sciences
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• v.46 no.2
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• pp.232-244
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• 2020

Objectives: The purpose of this study is to develop a management system for the safe handling of chemicals and related health management based on reporting under the Chemical Control Act (CCA). It is used to search handling information by constructing data linked to the name of companies, chemicals, products, etc. Methods: Due to the differences in submission periods for each reporting regulation of the Chemical Control Act, the data used is as follows: A statistical survey collected 26,222 companies in 2014 and 2016, Pollutant Release Transfer Registers (PRTR) collected 4,234 companies in 2015-2017, performance reports by handlers of hazardous chemical substances collected 14,658 companies in 2016-2018, and declarations for import of toxic chemicals collected 892 companies in 2016-2017. The total information on 36,080 companies is standardized based on company ID, name, business registration number, address, and more. The data were classified into information such as company, chemical, and product name and amounts handled and released, and then extracted according to criteria to establish relationships among classified information. Results: A search service was developed for handling information on chemical substances for reporting data by linking four reporting data: statistical survey, PRTR, performance report by handler of hazardous chemical substances, and declaration for import of toxic chemicals under the CCA. It was composed of five menus to search by regulation type, reporting regulation, companies and chemicals, and system management. Conclusion: It is necessary to use data linked by company, region, and chemical to respond and to prevent chemical accidents. In addition, these items can be utilized to perform handling and safety management of chemicals according to whether regulations under the CCA may be implemented.

• Journal of Korea Trade
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• v.27 no.2
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• pp.115-129
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• 2023

Purpose - This study empirically analyzes the consumer value of risk management associated with illegal, unreported, and unregulated (IUU) fishing of fishery products imported to Korea. The global regulatory paradigm for IUU fishing has shifted from production-centered to market-centered. As a result, changes in the international fisheries trade environment emphasizing "transparency" and "legality" of the production process are accelerating. Therefore, changes in the management systems of fishery products entering the country are also needed. Accordingly, this study estimated the consumer value for risk management of IUU fishing, targeting major fish species imported to Korea, and derived the feasibility of introducing related policies. Design/methodology - This study used the choice experiment as an analysis model to estimate consumers' willingness to pay for the "possibility to check for IUU fishing." The choice experiment assumes that the value of a good or service is composed of separable attributes and that the sum of the part-worth of these individual attributes becomes the total value. In this study, respondents were presented with profiles comprising three attributes (country of origin, price, and possibility of checking IUU fishing) and the levels of frozen poulp squid, the subject of the analysis. The participants were asked to select their preferred profile. The marginal willingness to pay for each attribute was derived from the results of the respondents' choices using conditional logit model estimates. Findings - There is a marked difference in utility based on the preference of the country of origin of fishery products among consumers. In addition, the utility of fishery products that have undergone IUU fishing verification was observed to be higher, with the utility marked to be higher for lower prices. Originality/value - Estimating the policy value of the risk management in IUU fishing of imported fisheries products in this study is a novel attempt that has never been conducted before. Several studies have been conducted to assess the risk of IUU fishing associated with the import of fishery products internationally. However, such studies are yet to be conducted in Korea. Instead, policies and studies have focused on issues related to complying with trading partners' legal and transparent standards for exporting fishery products. This study should be the beginning of more in-depth empirical and theoretical explorations to establish order in the domestic seafood market and respond to changes in international regulations on IUU fishing.

• Journal of Environmental Policy
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• v.14 no.2
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• pp.133-148
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• 2015

The number of used oil refining companies has been increased and it causes shortage of the volume of used oil per recycling company. In addition, the number of used oil collecting companies has been increased and it caused excessive competition among companies with excessive costs. Companies use not only proper used oil but also low quality used oil because of shortage of supply. It is the reason of environmental pollution. Also excessive competition brings high cost of refined oil and it becomes a burden on the consumer. Therefore, the recycling improvement plans of used oil is needed because of these causes. First of all, importing used oil from the developed countries of OECD is the one of solution to secure a used oil supply. However, imported used oil should meet the international quality standards and it is examined twice by international authority institute such as K-petro in both exporting and importing countries. Second, the cost would be reduced with the relaxation on regulations of used oil refinement. However, regulation to sediment and water should be separated. Sediment should be kept within 2% and water should be kept within 5%. It is the way to relax the regulations of used oil refinement with preventing environmental pollutions. Finally, the standard of used oil for heater should be regulated strictly. To prevent pollutions, used oil for heater is limited to high quality waste lubricating oil. Also the air pollution prevention device has to be installed on heater.

• International Commerce and Information Review
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• v.14 no.1
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• pp.221-246
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• 2012

The purpose of this study aims to analyse the case on the violation of the Agreement on WTO-TRIMs in the China with auto parts case. The Agreement on Trade Related Investment Measures(TRIMs) are rules that apply to the domestic regulations, a country applies to foreign investors, often as part of an industrial policy. The agreement was agreed upon by all members of the WTO. The TRIMs Agreement bans any laws, policies or administrative regulations favouring domestic products. This includes government incentives to encourage corporations to use domestically made products as a way of creating or protecting local jobs. The Agreement on TRIMs is only one such restriction within the broader WTO regime. Policies such as local content requirements and trade balancing rules that have traditionally been used to both promote the interests of domestic industries and combat restrictive business practices are now banned. In many ways the Agreement on WTO-TRIMs is less significant than the WTO agreements on services, etc. The TRIMs Agreement does not involve any new rules or disciplines, referring only to the existing provisions under the GATT. However, by enforcing GATT provisions on 'national treatment', this short and simple agreement has had farreaching effects on auto parts, etc. Meanwhile, China has been members of the WTO late 2001, once the measures imposed high-rate tariff for import parts was intended to regulate importer of auto parts in order to avoid the high-rate tariff.

• Journal of the Korean Home Economics Association
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• v.32 no.5
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• pp.165-182
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• 1994

Korea's clothing industry which has been country's leading export industry and basic strategical industry is now faced with many difficulties both domestically and internationally. Domestically it is faced with continuing shortage of manpower in both production line and management high labour cost causing increase in price putting more weight on behavior of consumers resulting in change of industrial environment and continuing structural problems of industry itself. Internationally it is faced with strengthening of import regulations and protectionism of developed countries and rapid emergence of underdeveloped countries as leading exporting nations. In reality export plays the most essential role in our economy and is especially sensitive to the external environmental factors. Already economic bloc phonomenon can be seen everywhere and is continuing to accelerate in place such as E. U in Europ, North & South America as NAFTA, and South East Asian contries which recent tendency of economic unity effort is present. These countries of such economic blocs are imposing heavy custom duties reinforcing provision of country origin and acting out strict inspection regulations in order to protect the interest of their own industry. Therefore it is vital to manufacture excellent quality goods For these reasons study in this area has brought attention in Korea as well as worldwide in the recent years. Apparel industry which requires professional technology and ability is the most competitive international business. In order to challenge the international market the high level of intelligence is most required to produce high quality goods. The purpose of this study is to analyze the relationship between functions and roles of marketing and to approach problems in more efficient manner. Apparel industry is composed of various programs such as design pattern making merchandising and textile science. To succeed in the business is to give the highest satisfaction to the targeted market. Hence this study will example the factors that determine the Cost Quality and Performance of apparel products. The study will involve following steps; firstly establish relationship between the quality concept and productivity of apparel products Secondly inquire in to marketing strategy laying stress on apparel production related factors focusing on merchandising marketing production and operations Thirdly prospect 21st century apparel industry focusing on garment production and trade and also other countries structural improvement Fourthly establish the new dimension of competitive factors by grasping the actual circumstance of Korea's apparel industry in the international market. The research method will include; First reality approach method by analysing the present state of industry Second literal analysis such as marketing comparisons between leading apparel exporting countries.

• International Commerce and Information Review
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• v.17 no.3
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• pp.177-201
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• 2015

Korea-China FTA was initialized in 2015. Korea has a high level of dependence on trade for its economic growth, especially to China. Technical Barriers to Trade(TBT) among various non-tariff barriers is becoming increasingly important. Elimination of TBT is one of the key issues in which the South Korean government is interested since technical barriers significantly affect trade between the two countries. MRA has been considered as an effective tool to relieve such technical barriers. Several studies and surveys showed that MRA would mitigate the barriers of import and solve the problems that many companies face in international market. This study tries to seek utilization plan of MRA for Korea-China FTA. It suggests suitable utilization plan of MRA considering the difference of technical regulations between two countries. This paper has value in that it provides specific MRA strategies targeting China while other prior studies have merely analyzed the necessity of MRA.

• Journal of Energy Engineering
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• v.5 no.2
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• pp.93-107
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• 1996

Six countries are considered in the study for the comparison of their respective gas industries with the Korean gas industry: the U.S., Canada, the U.K., France, Germany and Japan. The emphases of comparison are given on the cross-evaluation of industry organizations and related regulations. In terms of industrial development stages, the Korean gas industry, with its short experience and in need of more infrastructure, is still young and at an early stage of development. Due to this reason, the study finds that it is premature for the Korean case to propose some policies like the promotion of competition in the gas transportation through third-party access to pipelines. or seeking overseas business opportunities requiring venture capital and advanced technology. Recommendations are made that Korea rather, for the time being, concentrate its energy on the construction of infrastructure and on securing supply sources and diversifying import origins, in order to strengthen it's supply capability in the face of rapidly increasing gas demand in the nation. Nevertheless, Korea will soon have to consider more seriously about the deregulation of the market and more diversified business activities through the development of high technology and managerial skills.