• Journal of Acupuncture Research
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• v.32 no.4
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• pp.91-102
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• 2015

Objectives : The Oriental medical device industry is expected to continue to experience significant growth. It should increase its global market share rather than focusing on the domestic market. Countries around the world self-regulate their domestic market, so this study aims to aid in the development of a particular overseas market by introducing the U.S.(the largest market) medical device registration and approval process. Methods : For an understanding of the US medical device licensing process, we researched the relevant regulatory organization (FDA), the history, definition and classification of medical devices, the approval and 510(k) submission process related to substantial equivalence, IEC 60601-1 Edition 3, usability tests, and so on. Results : Medical devices in the United States are assigned to one of three regulatory classes: Class I, Class II and Class III, based on the level of control necessary to assure the safety and effectiveness of the device. If a company's device is classified as Class II and if it is not exempt, a 510k will be required for marketing. 1) A 510(k) is a premarket submission made to the FDA to demonstrate that the new device to be marketed is "substantially equivalent" to a legally marketed device (predicate device) 2) The IEC 60601-1 Edition 3 preparation process, which contains information related to usability, is expensive and time-consuming but a critical requirement. Conclusions : Although the U.S. market has high barriers to entry, access to this, large overseas market will encourage development of the Oriental medical device industry and commercial value enhancement is expected.

• Current Industrial and Technological Trends in Aerospace
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• v.7 no.2
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• pp.106-114
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• 2009

Until now, The Market of aviation parts had led by OEM(Original Equipment Manufacturer) parts because of aviation industry's nature required higher reliability and safety. But recently, The interest about PMA parts in aviation market is increasing continuously with various environmental changes, such as economic stagnation, oil price rise, development of the manufacture technique and newly rising market of Asia-Pacific region. Actually, after 2006, FAA PMA approval parts are increasing at a rate of around 40,000 parts per year and 2.5% of PMA parts penetration, in 2007, in Asia-Pacific market is forecast to enlarge up to 8% in 2017. So, this paper introduces the process requirements of FAA PMA / EASA EPA and the status of PMA market in order to enhance understanding for certification for aviation parts and to review a new PMA market.

• The Transactions of the Korea Information Processing Society
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• v.4 no.8
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• pp.2060-2069
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• 1997

Information processing using computer in generalized in the office automation. In spite of to be integrate and concise form of document through computer network, signature of document with hand have processed as ever. The security on document flow out severely unjust by reason of increment inverse function of computer. Because of revelation secret of enterprise result from unjust outflow, lots of loss of self-enterprise is occured. In this paper, we used efficiently document using the method, electronic approval system with encryption, for the resolving above problems. Also we persue maintenance of security for the important document and process document signature rapidly. Finally, we design and implementation of electronic approval system that take one's share of function between server and client using to be transformed Vernam's encryption technique in stored document.

• Korean Journal of Clinical Pharmacy
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• v.31 no.1
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• pp.1-11
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• 2021

Objective: This study aimed to overview and assess the effectiveness of the policies and regulations that have governed new drug access in Korea, and to propose policies to enhance patient access to drugs, particularly for new innovative medicines. Methods: We approached drug access issues in two perspectives: approval lag (or availability) and reimbursement lag (or affordability). The issues were identified and evaluated through the review of literature, public documents, reports published by the government agencies and private organizations, and news articles. Results: To shorten approval lag, it is recommended to hire and train more reviewers at the Ministry of Food and Drug Safety. Increasing user fees to a realistic level can facilitate this process. To reduce reimbursement lag, flexible incremental cost-effectiveness ratio threshold, alternative cost-effectiveness evaluation, and establishment of funding source other than the national health insurance are identified as the areas to be improved. Conclusion: The current policies and regulations had to be supplemented by new systems to drastically promote patient accessibility to new drugs, consequently in order to promote national public health.

• Journal of Auto-vehicle Safety Association
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• v.13 no.4
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• pp.20-25
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• 2021

This paper is the result of a research on hybrid tuning technology developed to improve the actual fuel efficiency and reduce emissions of in-use light-duty diesel trucks. In this study, a hybrid powertrain was constructed by inserting an electric motor between the diesel engine and manual transmission of an internal combustion engine vehicle and installing a battery. To verify the safety, a test was conducted based on the Korean tuning regulations. In particular, since there has been no case of tuning an internal combustion engine vehicle into a hybrid vehicle in Korea, it was necessary to carry out all procedures to receive tuning approval. The approval process consists of a technical review, safety verification test, and application for tuning approval. As a result, the test vehicle was approved for tuning because both the technical review and vehicle test results were suitable. Therefore, this study confirmed the safety of diesel hybrid tuning technology, and laid the foundation for the research and development of technologies to tune into an eco-friendly vehicle as well as the activation of related industries.

• Proceeding of Spring/Autumn Annual Conference of KHA
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• 2004.11a
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• pp.375-380
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• 2004

Restricting reconstruction, demand of remodeling has increased in deteriorated apartment. But remodeling process and steps are not taken, it is difficult to advance smoothly. Therefore, this study indicates improvement plans and understands the problems In advancing remodeling. In the result of the investigation the problems are the resident of agreements and legal approval. The goverment must complete laws about remodeling. Also, residents and an association need plans for conversation.

• Proceedings of the PSK Conference
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• 2003.10a
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• pp.35-37
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• 2003

Efficacy and safety of drugs are evaluated in the process of drug registration along with the basis of setting test method and acceptance criteria for assuring quality of the drugs. Quality of drugs plays a key role to guarantee the efficacy and safety of drugs approved in the evaluation process at the marketing stage after approval. Most important role of pharmacopoeia is to give the basis of assuring the quality of drugs. (omitted)

• The Journal of Korean Medicine
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• v.35 no.3
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• pp.135-154
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• 2014

Purpose: There is an issue in applying various principles introduced in established Korean medical classics to "Pharmaceuticals Approval, Notification and Review" of "herbal medicinal preparations" and "new drugs from natural products" that are used for western forms of medical treatment. Thus, an analysis of the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act is essential. Methods: We collected data regarding the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act, and classified them by periodical change and subjects. Results: Established Korean medical classics are applied as follows: 1) as criteria for Korean medicine distributors' sales of mixed herbal drugs (Pharmaceutical Affairs Act; since 1953), 2) as official compendiums for pharmacists' preparation of Korean medicine (Ministry of Health and Welfare's authoritative interpretation; from early 1970s to 1993), 3) as standards for oriental pharmacists' quality measurement of preparations (notification of the Ministry of Health and Welfare; since 1995), 4) as criteria for "Pharmaceuticals Approval, Notification and Review" of herbal medicinal preparations and crude drug preparations (notifications regarding drug approval process by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety; since 1978), and 5) as standards for the quality of materials of health functional food (from 2004 to 2011). Conclusion: The application of Korean medical classics has been closely related with the change of the laws, regulations, and systems that are relevant to Korean medicine, and it seems to be more favorable for pharmacists than oriental pharmacists. Meanwhile, regulations that apply prescriptions that are recorded in Korean medical classics - dosage, indications, and preparation methods - as criteria for the approval of crude drug preparations for western medical treatment should be abolished.

• Quality Improvement in Health Care
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• v.1 no.1
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• pp.32-43
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• 1994

The 'Pharmacy and Therapeutic Committee' decided to restrict the use of vancomycin which was categorized into restricted antimicrobials, among general, reserved and restricted antimicrobials. The committee also established prescribing guidelines of vancomycin in Seoul National University Hospital, May, 1991. Especially, the restricted antimicrobials should be used after approval by infectious disease specialist physician. A retrospective drug use evaluation (DUE) on vancomycin has been conducted to compare with the previous vancomycin DUE study in 1990. 'Criteria for DUE on vancomycin' was modified from Am J Hosp Pharm. Total 65 charts of patients were retrospectively reviewed from July 1991 to June 1992 in Seoul National University Children's Hospital. The justification of use was improved from 56% to 75% comparing with the previous study. In analyzing process indicators, several criteria including body temperature monitoring, WBC monitoring and use of concomitant antibiotics were well documented, but serum creatinine monitoring, culture and sensitivity test and level monitoring were infrequently performed, while the accepted level has been improved. Accepted level for appropriate initial dosage and duration of therapy were decreased. In outcome analysis, blood culture after discontinuing the drug was relatively well documented compared with the previous study. As the results, the approval vancomycin use was shown to be effective and rational in antibiotic therapy. And it is suggested that the above findings should be communicated to the medical staff, and a active intervention, such as feedback control, also be necessary for rational drug use.

• Journal of the Korean Society for Marine Environment & Energy
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• v.12 no.3
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• pp.209-216
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• 2009

IMO has established International Convention for the Control and Management of Ships' Ballast Water and Sediment 2004 in February 2004 in order to prevent transfer of aquatic organisms through ballast water. According to the Convention, Each countries are preparing ratification and legislation process and encouraging the development of treatment system to satisfy the performance standard in the Convention. This Electro-$Cleen^{TM}$ treatment system was granted IMO basic approval in March 2006, and final approval in October 2008. The Type Approval Certificate was issued in December 2008 by the Government of Republic of Korea. This paper considers the matter of principle mechanism, overview of the system, installation on shipboard and shipboard test results for the Electro-$Cleen^{TM}$. Shipboard tests with the 8300 GT M/V Yokohama and 27,000 DWT M/V Greenwing have already been conducted. These tests confirmed that the Electro-$Cleen^{TM}$ system satisfies all of the IMO standards and is suitable for installation in new and existing ships.