• 통상정보연구
• /
• 제17권3호
• /
• pp.93-114
• /
• 2015

본 연구에서는 중국시장에서 우리나라의 국제경쟁력을 보유한 수출특화품목을 도출하기 위하여 RCA지수, MCA지수, TSI지수를 통해 우리나라와 중국 의료기기산업의 국제경쟁력을 분석하였으며 도출된 국제경쟁력 지수를 그룹화하고 연도별로 변화추이를 살펴보았다. 우리나라는 중국시장에서 우리나라 의료기기 품목의 경쟁력을 강화하기 위하여 지속적으로 중국 의료기기 시장 동향을 분석하고 중국시장에서 우리의 시장점유율과 경쟁우위를 파악하여 수출특화품목을 도출하고 발굴해야 할 것이다.

• 품질경영학회지
• /
• 제50권3호
• /
• pp.503-515
• /
• 2022

Purpose: As ISO 13485 was revised in 2016, the domestic GMP (Good Manufacturing Practice) system was also revised and implemented in 2019. However, there are many problems in the domestic medical device industry because most of the small and medium-sized enterprises lack human and material resources. Accordingly, this study was conducted to provide education programs for domestic medical device companies to induce information provision and improve the company's quality management ability. Methods: First, analyze existing education. Second, based on the revised GMP system, a survey paper was produced to investigate difficulties and problems experienced by companies. Third, a two-week survey was conducted on domestic medical device manufacturers, and a total of 77 companies responded to this survey. Fourth, educational program development was conducted based on the results of the survey. Results and Conclusion: The developed education program consists of a total of five sessions. In this study, the educational program developed by grasping the needs of the company through a survey consists of a total of five sessions. The first session consisted of theoretical education and the second to fifth sessions of practical education. Through the education program developed in this study, it is expected to contribute to the overall development of medical device quality by establishing a domestic medical device manufacturing environment that secures the safety and performance of domestic medical device companies.

• 대한안전경영과학회지
• /
• 제12권3호
• /
• pp.37-52
• /
• 2010

This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).

• 보건의료산업학회지
• /
• 제7권3호
• /
• pp.203-212
• /
• 2013

Medical devices separated by a committee of the International Electrotechnical Commission IEC TC (Technical Committee) 62 medical electrical equipment being promoted by the International standards. Actually, a lot of standards were existed, but many national and international standards for medical devices were lacking in practical standards that can be applied to their development. Most international standards were focused in electrical and mechanical safety of medical devices. Therefore, there were few practical standards which contain essential performance evaluation. Although medical device regulations do not enforce a fixed lifecycle model, activities are presented in a sequential manner, thus hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from agile development methods. Several medical device manufacturers have adopted agile practices while keeping development in compliance with regulations, but conflicts arise and decisions have to be taken in favor of agility or formality. However, if there are new practical standards of medical devices, it must be possible to promote the medical devices industry in their nation. To do this, there is a need to develop a new standard could apply to the international market through the analysis of the medical device related technology. Consequently, new standards such as NP (New proposal) or NWIP (New Work Item Proposal) should be developed through international standardization of medical device technology.

• 경영과정보연구
• /
• 제35권2호
• /
• pp.221-254
• /
• 2016

인구 고령화로 건강에 대한 관심이 증가함에 따라, 의료기기산업은 성장 가능성이 매우 높은 미래 먹거리 산업으로 부각되고 있다. 하지만, 국내 의료기기산업은 협소한 내수시장과 영세한 기업구조로 인해 해외 글로벌 기업에 비해 시장경쟁력이 부족한 실정이다. 이에 국내기업이 국제경쟁력을 확보하기 위한 의료기기의 핵심기술이 무엇인지 도출하고 이의 흐름에 대해 파악해야 할 필요성이 대두되고 있다. 본 연구의 목적은 특허 네트워크분석을 통해 의료기기분야에서의 핵심기술을 예측하는 것이다. 핵심기술이란 해당 기술 분야에서 많은 기술들과 연결되어 있는 기술로써 현재 또는 미래시장에서 경제적 가치를 창출할 수 있는 기술, 조직의 생존과 관련된 전략적 가치를 가진 기술, 해당 분야의 기술전개 과정에서 중심적 역할을 하는 기술을 의미한다. 실증분석을 위해, Jun(2012)이 제안한 방법론을 활용하여 특허 IPC코드 간의 공분산 및 상관계수 값으로 소셜네트워크분석을 실시하였다. 또한, 보건산업통계의 의료기기 산업데이터를 활용하여 도출된 핵심기술의 해당 의료기기 품목에 대한 생산액을 검토함으로써 연구방법론의 타당성을 확보하고자 하였다. 분석결과, 중분류별로 선정된 핵심기술과 관련된 품목이 국내 의료기기 생산액 상위 품목에 부합되는 결과를 도출하였다. 국가 R&D 방향이 기술사업화라는 측면에서 볼 때 의료기기 핵심기술을 파악함으로써 미래 먹거리 기술을 도출하고 이에 대한 R&D 개발전략에 도움을 줄 수 있을 것으로 판단된다.

• 대한의용생체공학회:의공학회지
• /
• 제44권3호
• /
• pp.204-210
• /
• 2023

This study focuses on analyzing medical device standards and regulatory requirements in the medical device industry, based on the Medical Device Act in Korea. The objective of this analysis is to determine whether the domestic standards for medical devices in Korea align with international and regional standards. Furthermore, it aims to identify the current application of domestic standards in ensuring the safety and essential performance of medical devices. The analysis revealed that out of a total of 281 domestic standards, 127 standards reference international standards. In terms of the application of domestic standards to specific items, there were 473 types of instruments/machines, 30 types of medical supplies, and 45 types of dental materials. However, the level of compliance with international standards among the domestic medical device standards was only 21%. Upon detailed analysis, general and collateral standards accounted for 24%, while particular standards accounted for 19%. This indicates a significant deviation from the latest international standards. On the other hand, the level of compliance with international standards was analyzed to be 60% for particular standards and 72% for general and collateral standards in Korean industrial standards (KS). Considering these results, the disparities between domestic standards and international standards underscore the need for discussions on domestic medical device regulation and standardization. In conclusion, this study emphasizes the significance of maintaining up-to-date medical device standards and ensuring their alignment with international standards to ensure the safety and quality of medical devices. The findings highlight the necessity for further efforts to strengthen the domestic standardization system in order to promote the development of safe and high-quality medical devices.

• 한국노년학
• /
• 제30권3호
• /
• pp.803-814
• /
• 2010

2008년 7월 노인장기요양보험제도 도입으로 공적 급여가 시작된 장기요양서비스 중 복지용구는 노인의 자립생활 지원 및 가족의 수발부담 경감 효과가 기대되는 중요한 서비스이다. 새로운 제도 도입 후 일 년이 경과한 현 시점에서 소비자에게 직접 복지용구를 제공하고 있는 복지용구사업소의 운영 현황을 파악하고자 전국 복지용구사업소를 대상으로 우편설문조사를 실시하였다. 194개소의 조사 자료를 분석한 결과, 대부분의 복지용구사업소는 관리, 인력, 시설, 서비스 등의 측면에서 보완해야할 여러 가지 문제들이 발견되었다. 복지용구사업소의 월매출액은 평균 797만원에 불과하여 경영상 어려움을 가질 것으로 판단되었다. 또한 배상책임보험은 절반 정도만이 가입되어 있어 사고 시 대비할 수 있는 체계가 갖추어지지 않은 경우가 많았으며, 정규직 인력 평균 2.6명 중 사회복지사 및 물리치료사는 약 20%에 불가하며 전문적 교육을 이수한 경험은 거의 없었다. 뿐만 아니라 세정소독시설을 갖춘 사업소 중 오염청결구역을 구분하는 비율은 44.8%에 불과하여 실제 세정·소독의 의미가 없는 경우가 많았다. 이에 양질의 복지용구서비스가 이루어지기 위해서는 배상책임보험 가입을 통한 불의의 사고에 대비, 복지용구 관련 인력에 대한 교육, 대여 복지용구의 세정소독 관리 강화 등이 필요할 것으로 판단된다.

• Journal of Acupuncture Research
• /
• 제32권4호
• /
• pp.91-102
• /
• 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.

• 무역상무연구
• /
• 제64권
• /
• pp.213-237
• /
• 2014

The medical-device market of Myanmar in the recent Asian region is where the influences of Thailand, China, India and Singapore are being shown considerably with the lift-up of economic sanctions by America and the West. However, although the global capital and liberalization have widened the openness and the international concerns, the relative Myanmar's medical environment demands an active assistance and improvement. The study, recognizing the importance of Medical-Devices and their market conditions emerging as key business for knowledge-based industry, aims to obtain consequential meaningful suggestions, pursuant to relative export-concentration and sustainable market growth of Medical Devices, by analyzing inter-nation trade intensity for key Medical Device items. To do so, this study selected 8 nations in total by reviewing three points: core Medicine-advanced countries, geographically adjacent countries to Myanmar, and relative export-concentration.

• 산경연구논집
• /
• 제15권5호
• /
• pp.17-27
• /
• 2024

Purpose: The renminbi (RMB) has appreciated alongside the elevation of China's economic status, leading to increased exchange rate volatility. Moreover, China's medical industry saw a surge in import and export trade volume, with trade related to epidemic prevention and control in the medical sector significantly increasing its share. The medical device trade, in particular, occupies a substantial portion of this trade. Research design, data and methodology: This paper focuses on the import and export value of medical devices in the medical industry as a case study to explore the impact of RMB exchange rate fluctuations on the import and export trade of the medical industry during the pandemic. Additionally, it investigates whether the import and export trade of the medical industry can be a contributing factor to the fluctuations in the RMB exchange rate. Results: Through an empirical study on the import and export values of medical devices in the medical industry over the past three years, as well as the RMB exchange rate, this paper establishes a VAR model and conducts a series of tests including stationarity tests and cointegration tests. Conclusions: The conclusion is that fluctuations in the RMB exchange rate have a long-term impact on China's medical industry's import and export trade.