• The Journal of the Convergence on Culture Technology
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• v.8 no.5
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• pp.29-37
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• 2022

MDR, a new European medical device regulation newly enacted in 2017, requires that medical device products that have received CE conformity certification through MDD be re-certified by May 2024 in line with the new CE MDR regulation. The new MDR requires more stringent medical device clinical evaluation and clinical investigation than the previous MDD required, and also require the submission of documented post-marketing surveillance data. Korean medical device makers also need to meet the new MDR requirements and obtain conformity certification, but the industry is still confused because they do not understand the new regulations thoroughly. In this study, medical device regulations in Korea, the United States, and Europe are compared, and the European MDR is further compared with the previous European Medical Device Directive MDD to help understand the requirements of the new European Medical Device Act.

• 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.

• Journal of Service Research and Studies
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• v.4 no.2
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• pp.1-10
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• 2014

According to recent trends in technological advances and globalization, medical device industry may improve the constitution to meet worldwide medical equipment management system. Also it is holding a strand of mitigation to reach the level of international regulation. In addition, recent legislation tends are to stay limited ranges of industry regulations at least and take as open attitude for integration of new technologies combined medical devices. A greater environmental risk is not likely to work in medical technology, Combinded medical device is used as close to zero risk in most of the human body, which is classified as Class 1. Even medical device such as little or no risk in handling, it is possible to minimize the unnecessary administrative power and a waste of time to occur. For the medical device may be improving people's choices and access, medical equipment operator is expanding to include dealers, because this will be exalted to particular area of the business of the company. In this paper, we investigate the legal prerequisites for the establishment of a medical device. And propose improved regulations in topics in order to facilitate the repair and distribution markets for fair trade.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.75
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• pp.159-177
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• 2017

In this paper, we examined trends and regulations of the global medical equipment industry through literature search. The medical equipment industry is attracting attention as a new growth engine in the Fourth Industrial revolution. However, the medical device industry is a highly competitive field due to product diversity, short product life cycle and technological advances. In addition, Medical equipment are related to human health and safety. Therefore, it can only be exported if it is approved by national or international standards. Therefore, from the development stage of the product, the medical equipment should designate the country to be exported and develop a medical equipment that meets the requirements for licensing the medical equipment in the country. Therefore, In this paper, In this paper, we will present the practical considerations of the medical equipment exporting company by examining the global medical equipment market trends and the regulations related to medical equipment in major countries.

• Broadcasting and Media Magazine
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• v.24 no.3
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• pp.100-113
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• 2019

VR 기술 및 활용에 대한 다양한 연구와 장밋빛 전망에도 불구하고, 현재 우리 법 제도는 VR 산업 활성화의 걸림돌이 되는 규제들을 완전히 제거하지 못한 상태이다. 특히, 의료 및 게임 분야에서 VR 콘텐츠의 특수성을 고려한 맞춤형 규제설계가 필요하다. 먼저, 현행 규제상 의료용 VR 콘텐츠 및 소프트웨어는 의료기기 수입 제조허가와 신의료기술평가를 모두 거쳐야 하는데, 특히 신의료기술평가의 경우에는 의료용 VR 콘텐츠 및 소프트웨어에 대한 대비가 충분하지 않아 이의 활용에 상당한 장애가 될 수 있다. 그러므로 정부가 가이드라인 등 적절한 해석기준을 통해 의료기기의 범위를 불필요하게 확대하지 않도록 하고, 아울러 신의료기술평가에 있어 '선 진입, 후 평가' 제도를 활용할 수 있도록 개선이 요구된다. 다음으로, 게임의 경우에는 현행 게임산업법상 게임물의 정의가 너무 광범위하여 양방향성이 있는 VR 콘텐츠들이 게임물로 분류되어 불필요한 규제를 받을 가능성이 있으며, 여기에 더하여 최근 세계보건기구에서 '게임 이용 장애'를 국제질병분류에 포함시킴으로써 추가 규제에 대한 우려까지 더해지고 있다. 이러한 문제점을 해결하기 위해서는 법제처가 최근 발표한 "적극행정 법제 가이드라인"의 취지에 맞게 정부가 게임물 규제의 범위를 적극적으로 축소 해석하거나, 이러한 규제의 예외를 정하는 고시 또는 가이드라인을 제정할 필요가 있다. 또한, 현재 시행 중인 'ICT 규제 샌드박스' 제도를 잘 활용하고, 이와 별도로 국제질병분류의 국내 수용에 대해서도 보다 신중하게 접근할 필요가 있을 것이다.

• Journal of Service Research and Studies
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• v.4 no.1
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• pp.109-121
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• 2014

Used medical equipment utilized in medical technology, most are not human or environmental risks likely to in normal medical technology. Therefore, the risk is close to zero so that medical devices are classified into Class 1 medical device, such as little or no risk by treating. It can be minimized without arising unnecessary and waste of time. As handlers in the medical device vendors are expanding the area of the business, we can uplift operators' commitment to the business and for the people's choice. In this paper, our research are presented to improve the legal and regulatory directions for the distribution of used medical devicesin in order to establish and promote a fair deal of diversity.

• 건강소식
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• v.6 no.8 s.46
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• pp.23-28
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• 1982

FDA에서는 생물취급의 제품과 제제를 또 화장품을 그 밖에 의료기기에 대한 연맹에서 정해진 각기의 규제와 조례가 있다. 이에 따라 그 물품의 양부를 결정하고 안정성을 규제하고 유해성을 방비하는 검정사업 등을 한다.

• Convergence Security Journal
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• v.21 no.1
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• pp.63-72
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• 2021

The hospital biomedical engineering team is responsible for establishing and regulating the Medical Device Management Program (MEMP) to ensure that medical devices are safe and reliable. As technology advances, medical devices such as artificial intelligence and precision medicine are developing into a form that allows connection between objects anytime, anywhere, and as various technologies converge, internal and external security threats continue to increase. In this paper, we present a study of the Medical Device Management Program (Secure-MEMP) method, considering that the security threat of medical devices continues to increase due to advances in technology.

• Proceedings of the Korea Information Processing Society Conference
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• 2004.10a
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• pp.465-468
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• 2004

의료기기 산업은 시장규모와 생산규모에서 미국이 전 세계의 $40\%$ 이상을 차지하고 있어 국내외 모든 의료기기 제조업체에서는 미국시장진출을 목표로 꾸준히 노력하고 있는 실정이다. 그러나 의료기기는 인체에 직접 적용된다는 특성으로 인해 각 국가의 정부는 저마다 다른 엄격한 기준으로 자국내 시장진출을 규제하고 있으며 엄격한 관리제도를 유지하고 있다. 국내 최신의 전자 의료기기는 필수적으로 의료기기를 제어하기 위한 의료용 소프트웨어를 필요로 하므로 의료기기 산업의 발전은 의료용 소프트웨어 산업의 발전에 직결된다고 할 수 있다. 그러나 의료기기의 경우에는 인$\cdot$허가를 위한 제도 및 절차가 갖추어져 활용되고 있는 반면, 의료용 소프트웨어의 경우에는 적합한 평가기준이 마련되어 있지 못하여 제도 및 체계구축의 필요성이 대두되고 있다. 본 논문에서는 국제표준(ISO/IEC 12119, ISO/IEC 9126을 바탕으로 평가메트릭을 구축하여 의료용 소프트웨어의 정량적인 품질을 측정, 평가하여 품질측정의 결과를 토대로 품질을 인증하는 의료응용 소프트웨어 시험인증 지원도구를 설계 및 구현하였다.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.209-244
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• 2020

TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.