• Title/Summary/Keyword: International regulation

Search Result 1,119, Processing Time 0.027 seconds

Management and Regulatory Improvement of In Vitro Diagnostic Medical Devices Using Software: Proposals for Enhancing Domestic Regulations through Comparative Analysis of International Regulations (소프트웨어 활용 체외진단 의료기기의 관리 및 규제 개선: 국내외 규제 비교를 통한 국내 규제 개선 방안)

  • Soo Yeon Lim;Byeong-Ju Kwon
    • Journal of Biomedical Engineering Research
    • /
    • v.45 no.4
    • /
    • pp.148-161
    • /
    • 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.

Compliance of Electronic Bill of Lading Regulation in Korea with Model Law on Electronic Transferable Records

  • Choi, Seok-Beom
    • Journal of Korea Trade
    • /
    • v.23 no.3
    • /
    • pp.68-83
    • /
    • 2019
  • Purpose - The UNCITRAL Model Law on Electronic Transferable Records (Model Law) is based on the principles of non-discrimination against the use of electronic means, functional equivalence, and technology neutrality underpinning all UNCITRAL texts on electronic commerce. Investigating the disagreements between the Model Law and the Koran Commercial Act (KC Act), including the B/L Regulation, and suggesting the revision of the KC Act including the B/L Regulation, could be a valuable study. The purpose of this paper is to contribute to the harmonization of Korean legislation regarding electronic bill of lading in compliance with the Model Law. Design/methodology - The Model Law is flexible to accommodate the use of all technologies and models, such as registries, tokens, and distributed ledgers: that is, blockchain. In 2007, the KC Act was revised to regulate electronic bills of lading to promote the widespread legal use of electronic bills of lading. In addition, The Regulation on Implementation of the Provisions of the Commercial Act Regarding Electronic Bills of Lading (the B/L Regulation) was enacted to regulate the detailed procedures in using electronic bills of lading in 2008. This paper employs a legal analysis by which this paper does find differences between two rules in light of technology neutrality and global standard of electronic bills of lading model. Findings - The main findings are as follows: i) the Korean registry agency has characteristics of a closed system. ii) The KC Act has no provision regarding control. iii) The KC Act discriminates other electronic bills of lading on the ground that it was issued or used abroad. Moreover, this study does comprehensive analysis of Korean Acts in comparison with the Model Law and, in particular, this study analyzes the differences between the KC Act and the Model Law by comparing article by article in view of the harmonization of the two rules. Originality/value - The subject of previous several studies was draft provisions on Electronic Transferable Records before completion of the Model Law; thus, these studies did not take into consideration the character of the Model Law as the Model Law was chosen at the final stage of legislation. This study is aimed at the final version of the Model Law. So, this study is meaningful by finding the suggestion and directions for the Korean government to revise the KC Act and the B/L Regulation in line with the Model Law.

International Trends and Policy Recommendations Related to Non-Indigenous Species (외래종관리에 관한 국제동향 및 정책방향)

  • Park, Yong-Ha
    • Journal of Environmental Policy
    • /
    • v.1 no.1
    • /
    • pp.25-45
    • /
    • 2002
  • Opening of trade relationships through an increasing number of international free trade agreements and the now defunct General Agreement on Tariffs and Trade has resulted in an increase the number of the species being exchanged in the world. In the last 20 years, international environmental laws have multiplied and a number of treaties address harmful non-indigenous species (NIS) directly with specific provisions, while other treaties deal with related environmental issues and indirectly affect international regulation of NIS; however, such treaties are weak due to lack of enforceability. From the stand point of national law, many countries including the USA, Australia and New Zealand enforce national laws and regulations to protect biological resources. Typical strategies include : 1) strengthening quarantines to prevent unintentional and illegal introduction of harmful NIS, and 2) developing technologies for managing harmful NIS. However, the recent international trend for managing NIS has shifted. In 2002, the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefit Arising out of their Utilization was adopted at the 6th Conference of the Parties to the Convention on Biodiversity. One major issue highlighted in the document is that "there is no more free of charge to get a biological resource from other countries". The Bonn guidelines will affect international and national NIS regulatory systems because the NIS is a potentially disrupts ecosystems as well as native species. A number of impacts are expected including the revamping of national biodiversity policy regimes in many countries in the world. In particular, the ROK, which is not very biologically diverse, has to evolve national laws to protect valuable ecosystems from NIS. In the meanwhile, national rights of using beneficial indigenous and non-indigenous species as biological resources should be considered through the investigation and national registration of NIS around the world for the promotion of the biotech industry.

  • PDF

A Comparative Legal Study on the Non-Performance and Remedies under International Commercial Contract - Focusing on the CISG, PICC and PECL - (국제상사계약상불이행과 구제에 관한 비교 연구)

  • Shim, Chong-Seok
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
    • /
    • v.44
    • /
    • pp.3-29
    • /
    • 2009
  • The PECL have been drawn up by an independent body of experts from each member state of the european union under a project supported by the european commission and many other organizations. Salient features of the general provisions of the PECL, freedom of contract and pecta sunk servanda, good faith and fair dealing, most of the PECL are non-mandatory. The CISG uses the term fundamental breach in various setting. The concept of fundamental breach is a milestone in its remedial provisions. Its most important role is that it constitutes the usual precondition for the contract to be avoided(Art. 49., Art. 51., Art. 64., Art. 72., Art. 73). In addition, where the goods do not conform with the contract, a fundamental breach can give rise to a requirement to deliver substitute goods. Furthermore, a fundamental breach of contract by the seller leaves the buyer with all of his remedies intact, despite the risk having passed to him(Art. 70). Basically, PECL, PICC generally follows CISG, it was similar to all the regulation's platform though the terms and content sometimes differ. For example regarding to the non-performance and remedies, in the case of non-performance, that is the PECL/PICC term analogous to breach of contract as used in the CISG. Furthermore the PECL/PICC used fundamental non-performance refered to in PECL Art. 8:103 ; PICC Art. 7.1.1. correspond generally to the concept of fundamental breach referred to in CISG Art. 25. The main significance of the fundamental non-performance, in any systems, is to empower the aggrieved party to terminate the contract. The need for uniformity and harmony in international commercial contracts can be expected to lead to growth of international commerce subject to the CISG, PICC, and PECL. It is hoped that the present editorial remarks will provide guidance to improve understanding between the contractual party of different countries in this respect and following key-words.

  • PDF

The acculturation experience of Chinese international students in South Korea: Coping and perceived changes in the cultural transition (중국 유학생의 문화적응 경험: 대처와 지각 변화를 중심으로)

  • Lee, Yu Young;Kim, Hanjoo;Nam, Suk Kyung;Jin, Ling;Yang, Eunjoo
    • Korean Journal of School Psychology
    • /
    • v.8 no.3
    • /
    • pp.379-403
    • /
    • 2011
  • This study examined coping strategies and perceived changes of the Chinese international students in South Korea. A total of 56 Chinese students participated and data was analyzed using the concept mapping method. The results showed that Chinese international students adopted developing language proficiency and using social networks as important coping strategies. They also perceived a wide range of changes including changes in the cultural and personal self. However, the perception of these coping strategies and changes differed by the length of stay. Chinese international students who stayed longer reported using specific coping strategies for mood regulation, which was distinctive from the coping strategies used by students who stayed for a shorter period of time. Students who stayed longer perceived negative changes as well as positive changes, while students who stayed for a shorter period reported predominantly positive changes. The findings indicate that university staff needs to understand and sensitively respond to the distinctive experiences of Chinese international students which vary across time.

A Synthetical Study on Power Quality Measurement of Grid-Connected Wind Turbine Generating System based on the IEC International Standards (IEC 국제표준에 따른 계통연계형 풍력터빈 발전기계통의 전력품질 측정방법에 관한 심화연구)

  • Cho, Soo-Hwan
    • The Transactions of The Korean Institute of Electrical Engineers
    • /
    • v.63 no.2
    • /
    • pp.197-204
    • /
    • 2014
  • As more and more renewable energy resources are connected into the existing power system and their generation capacities are increasing, the need for regulations to minimize their impacts on the power grid is increasingly growing. And minimizing the irregular impacts made by grid-connected wind generators is important, since the output power generated by renewable energy resources can be changed easily by the weather condition and surrounding environment. In South Korea, an operational technical standard for distributed generation is used as a regulation, in which renewable energy sources including wind power are considered as a kind of distributed generation. In this paper, an international standard, IEC 61400-21, for the grid-connected wind turbine generating system(WTGS) will be introduced and a comprehensive and detailed review on the measuring methods of power quality characteristic parameters for WTGS based on the related IEC standards will be presented. Additionally, some prerequisites for applying the international standards to KEPCO system will be proposed.

Nutrient Amendments Influence Endophytic Colonization of Rice by Serratia marcescens IRBG500 and Herbaspirillum seropedicae Z67

  • Gyaneshwar, P.;Reddy, Pallavolu M.;Ladha, Jagdish K.
    • Journal of Microbiology and Biotechnology
    • /
    • v.10 no.5
    • /
    • pp.694-699
    • /
    • 2000
  • Serratia marcescens IRBG500 and Herbaspirillum seropedicae Z67 grow endophytically in rice. The ability of these bacteria to colonize rice grown under increased nutrient availability was assessed in variety IR72 using strains marked with transposon-based gusA. The endophytic colonization was monitored via bacterial enumeration and histochemical visualization of GUS expression of bacteria in plant tissues. Rhizoplane and endophytic colonization by both bacteria was significantly inhibited in the rice plants grown in the presence of 10 mM $NH_4Cl$. In contrast, the addition of 10 mM $KNO_3$ showed no adverse effect on colonization. Increasing the concentration of $Ca^{2+}$ to 5 mM significantly reduced endophytic colonization by both bacterial strains, whereas the addition of 0.5 mM $Fe^{2+}$ substantially lowered the colonization of roots by S. marcescens IRBG500 but showed no effect on colonization by H. seropedicae Z67. Taken together, these finding suggest that, like in legume-rhizobial symbiosis as well as plant-pathogen interactions, nutrient status, particularly $NH_4^+$ and $Ca^{2+}$ concentrations in the surrounding medium, plays an important role in the regulation of endophytic infection and colonization processes in rice.

  • PDF

Do Opaque Firms Prefer Liquidity? An International Evidence (불투명한 기업은 자산유동성을 선호하는가?)

  • Yim, Sang-Giun
    • The Journal of Small Business Innovation
    • /
    • v.19 no.1
    • /
    • pp.59-84
    • /
    • 2016
  • Using an international setting, this study investigates the relation between cash holdings and financial reporting quality, measured by accruals quality. Empirical results show that the balance of cash holdings is positively related to the opacity of financial reporting in non-U.S. international markets. The relation becomes stronger as the strength of investor protection increases, implying that precautionary motives, instead of agency motives, drive the increase of cash holdings of opaque firms. In addition, the positive relation is stronger for discretionary accruals quality. The decomposition of the aspects of investor protection shows that public enforcement through regulation authorities is the main driver of the positive relation between cash holdings and the opacity of financial reporting.

  • PDF

A Review on Limit of Liabilities of Multimodal Transport Operator in Korea (복합운송인의 책임제한 방식과 한도액)

  • SUR, Ji-Min
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
    • /
    • v.77
    • /
    • pp.145-168
    • /
    • 2018
  • The purpose of this paper is to introduce the limitation of liabilities of multimodal transport operators(MTO) in Korea. Also, this paper reviews the revised draft of Korean Commercial Code in 2015. This paper analyzes Korean multimodal transport systemand the limitation of liabilities of MTO by analyzing articles, regulations and practices of Korean Commercial Code and it's the draft in 2015. The paper, also, studies multimodal transport rules by comparing specifically international treaty, rules, or practices. In Korea, Article 816 of Commercial Code treats multimodal transportation adopting the network liability regime. The Article describes only the case of the multimodal transportation where the maritime carriage is engaged. Korea proposed the draft of multimodal transport regulation of Commercial Code in 2015 because present law could not apply for the multimodal transportation involved in the air or land carriage. This paper support the draft of Korean Commercial Code in 2015 because it is necessary to make a predictable legal system of multimodal transport and the limitation of liability reflecting practices or customs.

  • PDF

A Study on the Interface Model of Information sharing between nations for an efficient global SCM (효율적인 글로벌 SCM에 적합한 국가 간 정보 연계를 위한 인터페이스 모델 연구)

  • Park, Soo Min;Kim, Min Sik;Ahn, Kyeong Rim
    • Journal of Korea Society of Digital Industry and Information Management
    • /
    • v.8 no.4
    • /
    • pp.217-230
    • /
    • 2012
  • To look at Korea trade environment, as increasing the quantity of goods transported in North-East Asia and deepening national competitive, information-oriented logistics environment is needed. That means it is automated work process and can provide value-added service. To do this, logistics business can be efficiently handled through "Electronic Means for the Clearance of Ships" and electronically data processing. Also, by increasing the risk of international terrorism, regulation regarding to logistics security has strengthened around the advanced country, such as USA and EU, etc. or international organization, such as IMO, ISO, etc.. Furthermore, because trade and logistics environment is changing and security becomes more important in logistics area, movement or status information of goods within the port or in entry in/out becomes more and more be needed in real time. In case cross-border logistics activities, international cooperation or agreement between countries is very important. However, different opinions much happened on defining the interface. If to follow one format or type using at a specific country or organization, it was occurred to difficulty in respect of interoperability as well as additional costs or time. Therefore, this paper proposes common interface model to exchange information for the efficient global SCM for using by the output of Korea R&D project, "National Logistics Standardization System Development".