• Title/Summary/Keyword: Advanced medical device

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Changes and Perspects in the Regulation on Medical Device Approval Report Review, etc. : Focus on Traditional Korean Medical Devices (의료기기 허가·신고·심사 등에 관한 규정 변화와 전망 : 한의 의료기기 중심으로)

  • DaeJin Kim;Byunghee Choi;Taeyeung Kim;Sunghee Jung;Woosuk Kang
    • Journal of Society of Preventive Korean Medicine
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    • v.28 no.1
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    • pp.31-42
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    • 2024
  • Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

Licensing strategies and tasks for medical devices utilizing 3D printing technology in dentistry (치의학분야 3D 프린팅 기술이 적용된 의료기기의 인·허가전략과 과제)

  • Shin, Eun Mi;Yang, Seung-Min
    • The Journal of the Korean dental association
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    • v.56 no.9
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    • pp.479-490
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    • 2018
  • 3D printing technology supporting the specific patient medical services is actively being implemented in dentistry. The purpose of this study is to introduce the legal and institutional considerations to the medical practitioners in dentistry who must observe when they manufacture medical devices using 3D printers, and to provide a ways to activate and enhance their utilization in the domestic approval point of view for medical devices. Through the public data of government agencies and related organizations, the statutory system and compliance matters related to the manufacture of 3D printing medical devices have been examined and reviewed for the government's improvement efforts. Through the study, the government has been actively improving the system and making policy, but the active interest and participation of medical professionals and related workers are continually required to solve the problems which are scattered. 3D printing technology is expected to be more frequently utilized in the field of dentistry in near future. Therefore, it is essential to establish measures to improve the regulation through continuous cooperation with the related ministries with the long-term point of view enhancing smooth entry to the market for the medical devices by taking data from the continued research.

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Establish Selection Process of Performance Management Medical Devices and Test items Based on Risk Management (위험관리기반의 성능관리 의료기기 선정 절차 수립 및 시험 항목 도출)

  • Park, Ho Joon;Jang, Joong Soon
    • Journal of Biomedical Engineering Research
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    • v.40 no.1
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    • pp.20-31
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    • 2019
  • Medical device performance management is an activity that allows a device to be safely used and maintained even after it is put on the market. The purpose of this study is to provide procedures and criteria for selection of medical device items that should manage the safety and performance among medical devices in hospital. Investigate the performance management status of medical devices in hospitals and identify the performance management status by domestic and advanced regulatory agencies. Provides selection procedures and test methods for medical devices subject to performance management in hospitals based on medical device risk management and reliability. In addition, a case study on drug infusion pumps was conducted.

The Theoretic Approach of the New Policy (Autopoiesis) for Development of Stakeholder-Oriented Multidimensional Convergence Healthcare Industry (사용자 중심의 다차원적 융복합헬스케어산업 발전을 위한 새로운 정책(Autopoiesis)의 이론적 근거와 방향)

  • Lee, Hyung Bae;Lee, Tae Gon;Ryu, Gyu Ha;Lee, Kyu-Sung
    • Journal of Biomedical Engineering Research
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    • v.38 no.4
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    • pp.205-210
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    • 2017
  • The convergence healthcare industry in Korea has been stalled due to conflicts between stakeholders as well as a supplier-centered industry structure. This situation is caused by the structural contradiction in which the Korean industry has a prolonged conflict structure among stakeholders due to a strong regulation and an institutional inertia from the viewpoint of the sociotechnical system. Therefore, it is necessary to identify new system management plan that enhances social acceptability such as laws, customs and ideas while reducing conflicts between stakeholders. In this study, mainly adapting the stakeholder-oriented autopoiesis and focusing on publicness of healthcare, we propose the rationale and direction for policy making to harmonize various systems within the convergence healthcare industry.

A Study on Safety and Performance Evaluation of Smart All-in-one Cardiopulmonary Assist Device (스마트올인원 심폐순환보조장치의 안전성 및 성능평가에 관한 연구)

  • Park, Junhyun;Ho, YeJi;Lee, Yerim;Lee, Duck Hee;Choi, Jaesoon
    • Journal of Biomedical Engineering Research
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    • v.40 no.5
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    • pp.197-205
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    • 2019
  • The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

Evaluation of Present Status from Health Technology Assessment(HTA) through case analysis in dentistry (치의학분야 사례분석을 통한 신의료기술평가 현황 평가)

  • Son, Gi Tae;Yang, Seung-Min
    • The Journal of the Korean dental association
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    • v.57 no.6
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    • pp.316-324
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    • 2019
  • The new medical technology assessment system has a basic goal of protecting the public's health rights and promoting the development of the new medical technology with safe and effective medical technology that has been scientifically proven. The purpose of this study is to contribute to the activation of the new medical technology evaluation system by analyzing the application cases of the dental field after the implementation of the new medical technology evaluation system and proposing an efficient approach to approach the new medical technology evaluation system. The number of related literature and medical technology evaluation results are not significant in dental applications, the number of cases and the length of follow-up period of the relevant medical technology adopted as the new medical technology was far higher. As the speed of medical technology development increases, medical technology is expected to develop in the dental field as well. To introduce the medical technology to the clinical site, access to the correct direction of evidence is required to collect and objectify data at the medical site in order to prepare a literary basis for the medical technology.

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A Study on the Market of Imported Medical Devices in Myanmar

  • Bae, Hong Kyun
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
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    • v.64
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    • pp.213-237
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    • 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.

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Class E Power Amplifiers using High-Q Inductors for Loosely Coupled Wireless Power Transfer System

  • Yang, Jong-Ryul;Kim, Jinwook;Park, Young-Jin
    • Journal of Electrical Engineering and Technology
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    • v.9 no.2
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    • pp.569-575
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    • 2014
  • A highly efficient class E power amplifier is demonstrated for application to wireless power transfer system. The amplifier is designed with an L-type matching at the output for harmonic rejection and output matching. The power loss and the effect of each component in the amplifier with the matching circuit are analyzed with the current ratio transmitted to the output load. Inductors with a quality factor of more than 120 are used in a dc feed and the matching circuit to improve transmission efficiency. The single-ended amplifier with 20 V supply voltage shows 7.7 W output power and 90.8% power added efficiency at 6.78 MHz. The wireless power transfer (WPT) system with the amplifier shows 5.4 W transmitted power and 82.3% overall efficiency. The analysis and measurements show that high-Q inductors are required for the amplifier design to realize highly efficient WPT system.

The Analysis and Strengthening Method of Export Competitive Power of Medical Device Industry - With Respect to Medical Device Industry in Gangwon Area (의료기기산업의 수출경쟁력 분석 및 강화방안 -강원지역 의료기기산업을 중심으로-)

  • Lee, Kang-Bin
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
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    • v.45
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    • pp.191-238
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    • 2010
  • The purpose of this paper is to make research on the trend of the worldwide medical device market, the trend of the medical device market in the major foreign countries, the present status of the medical device industry in Korea and Gangwon area, the present status of export competitive power and the SWOT analysis of competitive power of the medical device industry in Gangwon area, and the strengthening methods of export competitive power of the medical device industry in Gangwon area. As the research method, the questionaire for the strengthening of export competitive power of the medical device industry in Gangwon area was carried out from August 13 to Otober 22, 2009. The worldwide medical device market in 2008 is estimated at USD 210.2 billion, with the United States being the largest market, followed closely by Japan and Western Europe. In 2006, the worldwide export amount of medical devices recorded USD 121.1 billion and the worldwide import amount of medical devices recorded USD 126.3 billion. As of the end of 2008, the number of Korea's medical device manufacturers expanded to 1,726. The production amount of Korea's medical device industry in 2008 recorded 2,525 billion won, and the domestic market volume of medical devices in 2008 recorded 3,618 billion won. Korea's export amount of medical devices in 2008 recorded USD 1,132 million and recorded a 9.67% growth compared to the previous year, and the import amount of medical devices recorded USD 2,123 million and recorded a 1.43% reduction compared to the previous year. As of the end of 2008, the number of Gangwon area's medical device manufacturers expanded to 81. The production amount of Gangwon area's medical industry in 2008 recorded 380 billion won, and Gangwon area's export amount of medical devices recorded USD 269 million and recorded a 0.25% reduction compared to the previous year, and the import amount of medical devices recorded USD 3 million and recorded a 39.63% reduction compared to the previous year. According to the result analysis of the questionaire for the strengthening of export competitive power of medical device industry in Gangwon area(August 13~October 22, 2009), the competing country of the export medical device is the United States being the highest ranking. Comparing to the collective competitive power level 100 of the competing country, the collective competitive level of the export medical device is 60 below and 70-80 below being the highest ranking. Comparing to the quality level 100 of the United States, EU and Japan, the quality level of the export medical device is 80-90 below being the highest ranking. Comparing to the design level 100 of the United States, EU and Japan, the design level of the export medical device is 90-100 below being the highest ranking. Comparing to the technology level 100 of the United States, EU and Japan, the technology level of the export medical device is 80-90 below being the highest ranking. According to the SWOT analysis of competitive power of medical device industry in Gangwon area, the strength is the abundant expert manpower of the medical device in Wonju area. The weakness is the fragility of the brand recognition of the medical device industry. The opportunity is the demand increase of the new medical device owing to the advanced age of population. The threat is the difficulty of entry into overseas market owing to the request of the new specification certification of the medical device. In order to strengthen the export competitive power of the medical device industry in Gangwon area, the following measures should be taken by the government, local self-government body, related organization and medical device industry : the development of new technology and design, the enhancement of brand recognition. the acquisition of the foreign specification certification, the building of overseas distribution channel and after sales service channel, the positive participation in overseas medical device exhibition and opening of medical device exhibition, the training of expert manpower, the strengthening of overseas marketing, and the application of FTA and the establishment of counter measures against FTA. In conclusion, the medical device industry in Gangwon area has the difficulty in the entry into the overseas market owing to the shortage of overseas marketing capability. Therefore, the government and local self-government body should make the intensive and systematical support for overseas marketing of the medical device industry. For the support of overseas marketing, the government and local self-government body should provide positively the support of expenses for the acquisition of foreign specification certification, the support of participation in the overseas medical device exhibition, the despatch of market development mission, the increase of the support amount for R&D investment fund, and the training of expert manpower of medical devices.

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The Strategy of Overseas Market Entry of Medical Device (의료기기의 해외시장 진출방안에 관한 연구)

  • Chung, Jaeho
    • Proceedings of the Korea Contents Association Conference
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    • 2009.05a
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    • pp.1210-1215
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    • 2009
  • The domestic medical device industry compared by advanced nations continues a quick growth, also the level of technique is gradually improving. However, the high import percentage, low investment, shortage of professional manpower and etc. are remained as weaknesses in the competitive circumstance. In this paper I researched world medical device market and industry, and tried to find the development plan of the domestic medical device. The approach could be in mid-long term rather than short-term, The institutional improvement and support of the government, the production complex, the market segmentation and overseas marketing reinforcement and etc. are necessary for export expansion plan.

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