• 대한예방한의학회지
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• 제28권1호
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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.

• Journal of Acupuncture Research
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• 제32권4호
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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.

• 대한치과의사협회지
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• 제56권9호
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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.

• 대한의용생체공학회:의공학회지
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• 제31권4호
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• pp.280-284
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• 2010

Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.

• 대한방사선기술학회지:방사선기술과학
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• 제39권2호
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• pp.263-271
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• 2016

최근 인구 고령화에 따른 골다공증 환자의 증가 및 의료기기 시장의 성장으로 인해 엑스선골밀도측정기 시장이 커지고 있으며, 이에 따른 의료기기 허가 심사건수가 증가하고 있다. 의료기기 기술문서는 의료기기의 허가 심사 시 가장 기본이 되는 문서로 필수 제출 첨부자료 중 하나이다. 기술문서는 의료기기 관련 법령 및 고시에 그 근거를 두고 있으며, 의료기기 전반적인 항목을 기술해야하는 만큼 작성자의 전문성이 필요한 항목이다. 하지만 최근 부정확한 작성의 증가로 인한 심사자들의 업무부담이 증가되고 있어 민원 처리 효율이 저하되고 있다. 특히 엑스선골밀도측정기의 경우 식품의약품안전처 기준규격이 없어, 의료기기 제조/수입업체 등에서 시험항목을 설정하는 데 많은 어려움을 겪고 있다. 따라서 본 연구에서는 개선된 제도가 반영된, 엑스선골밀도측정기 기술문서 작성 가이드라인 개발을 위해 첫째, 개선된 제도 운영에 대한 조사, 품목별 의료기기의 제도 적용에 따른 문서 작성 방법 검토, 기 허가된 품목에 대한 허가 및 기술문서 검토를 완료하였다. 둘째, 품목별 시장현황 조사, 적용 가능한 국내 외 규격을 조사 분석하여 품목별 국제조화된 안전성 및 성능평가 시험기준 및 방법을 도출하였다. 마지막으로, 산 연 관 전문가협의체 논의를 거쳐 기술문서 작성 가이드라인(안)을 최종 도출하였다.

• 의료법학
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• 제15권2호
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• pp.63-89
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• 2014

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

• 대한의용생체공학회:의공학회지
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• 제38권3호
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• pp.89-94
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• 2017

In order to improve national competitiveness through technological research and development, the government puts in R&D budget every year and manages to improve the R&D results. Accordingly, various R&D project management methods have applied for successful advancement of technology and product. TRL is a measurement system developed by NASA to assess the maturity of technology since the 1970s. To apply medical device, the characteristics such as regulation, clinical trials are considered as a significant influence. In this study, we would like to derive PMI(performance measures index) for medical device R&D projects by using TRL and stage-gate model. As a result of this study, it is possible to use the PMI for decision making and evaluation in the R&D projects and believed that the objectivity can be ensured by the approval or certification of regulatory authority.

• Genomics & Informatics
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• 제12권4호
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• pp.151-155
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• 2014

In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.

• 대한방사선기술학회지:방사선기술과학
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• 제39권4호
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• pp.651-660
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• 2016

최근 인구고령화로 인하여 치과진료 주요대상인 노인층의 검사가 꾸준히 증가하고 있다. 따라서 치과 진단용 엑스선장치 시장도 꾸준히 성장하고 있으며, 동시에 치과용엑스선장치의 허가 심사건수도 증가하고 있다. 의료기기 기술문서는 의료기기의 허가 심사 시 필수로 요구되는 자료이며, 해당 의료기기의 전반적인 항목을 기술해야 하는 만큼 작성자의 업무 이해도 및 전문성이 필요하다. 그러나 국내 의료기기 제조 수입 업체 대부분이 영세하여 의료기기 인 허가 관련 전문 인력의 확보가 쉽지 않아, 이로 인한 기술문서의 부정확한 작성이 증가하고 있다. 이에 따른 심사자의 민원 처리 지연과, 제품의 신속한 시장 진입의 어려움이 발생되고 있다. 특히 치과용구강외엑스선장치, 치과용구강내엑스선장치, 암형전산화단층엑스선촬영장치, 포터블엑스선 촬영장치(이하 치과용엑스선장치)는 식품의약품안전처 기준 규격이 최근에 제정되거나 부재한 품목으로, 의료기기 제조 수입업체에서 시험항목 설정 시 많은 어려움을 겪고 있기에, 개선된 규격이 반영된 치과용엑스선 장치 가이드라인(안)을 개발하여 관련 업체 및 심사자에게 도움을 주고자 한다. 본 연구를 위하여 첫째, 기술문서에 대한 개선된 제도 운영 조사 및 의료기기의 제도 적용에 따른 문서 작성 방법을 검토하였으며, 둘째, 품목별 시장현황을 조사하고, 국내 외 규격을 분석하였으며, 셋째, 기 허가된 제품의 기술문서를 분석하여 품목별 올바른 작성방법과 국제조화된 시험항목, 기준 및 방법을 도출하였다. 마지막으로, 산 연 관 전문가 협의체 회의를 통하여, 공정하고 전문성이 강화된 기술문서 작성 가이드라인(안)을 도출하였다.

• 의료법학
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• 제21권2호
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• pp.209-244
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• 2020

TMS와 tDCS는 자기와 전류를 통하여 뇌에 자극을 가함으로서 환자나 개별 이용자의 질병을 치료하고, 이외에도 건강을 관리하거나 증진시킬 수 있는 비침습적 기기를 말한다. 이들 기기의 효과와 안전성은 몇몇 질병에서 입증되고 있으나, 아직도 이에 대한 연구는 진행 중이다. 점차 증가하고 있는 이들 기기의 활용도에 비해 TMS와 tDCS를 직접 규율하는 입법례를 찾기는 어렵다. 미국, 독일, 일본의 TMS와 tDCS에 대한 법적 규율을 살펴보면, TMS는 중등도의 위해도를 가진 의료기기로 승인되어 있는 반면, tDCS는 아직 의료기기로 승인된 상태는 아니다. 하지만, 최근 FDA 가이드집이나 유럽 MDR 규정의 변화, 미국의 리콜사례, 독일과 일본의 관련 법 규정, 전문가 그룹의 제언 등을 검토하면, tDCS도 조만간 의료기기로 승인되어 규율될 것으로 보인다. 물론, tDCS를 의료기기가 아닌 일반제품으로 보더라도 다른 법률과 제도를 통하여 제품의 안전성과 효과를 규제할 수는 있다. 그러나 이 기기가 인간의 뇌에 미칠 수 있는 여러 영향을 고려할 때, 이를 독자적으로 규율할 필요성이 크다. 우리도 TMS와 tDCS를 규율하는 명시적 법률은 없으나, 이 두 기기는 식약처 고시에 따라 3등급 의료기기로 판정된다. 그리고 TMS는 가이드 라인에 따라 미국 FDA 지침에 의해 안전성과 성능을 평가하도록 하고 있다. 하지만, tDCS는 아직 이에 대한 구체적 지침은 존재하지 않는다. tDCS 기기가 일부 병원에서, 그리고 개별 구매자를 통하여 가정에서 사용되고 있는 현실을 고려하면, 이러한 규제의 공백은 신속히 보완되어야 한다. 장기적으로는 비침습적 뇌자극기기를 독자적으로 규율할 수 있는 법적 시스템의 정비가 필요하다.