• 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.

• 대한의용생체공학회:의공학회지
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• 제43권3호
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• pp.153-160
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• 2022

As new types of medical devices are emerging through convergence with advanced technology, innovative technologies are becoming hot issues in health policy because of their disruptiveness. This study analyzed the innovative medical device management systems in the US, China and Korea. Innovative medical devices have been defined differently depending on the country's management system, but in common, they are defined as products that do not exist or have dramatically improved performance compare to existing products by applying innovative technologies. Innovative medical devices have been supported by regulatory authorities during product development and approval processes. While the US and China have more than 300 products designated as innovative medical devices with diverse functions, application fields, and manufacturing countries considering the initial situation of the implementation for the system, Korea has only 16 products, mainly radiology and diagnostic devices and made in Korea only as innovative medical device. In addition, Korea shows the highest market approval rate of innovative medical devices compare to the US and China, and it is necessary to prepare the approval process in consideration of product diversity.

• Korean Journal of Radiology
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• 제22권3호
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• pp.442-453
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• 2021

Artificial intelligence (AI) will likely affect various fields of medicine. This article aims to explain the fundamental principles of clinical validation, device approval, and insurance coverage decisions of AI algorithms for medical diagnosis and prediction. Discrimination accuracy of AI algorithms is often evaluated with the Dice similarity coefficient, sensitivity, specificity, and traditional or free-response receiver operating characteristic curves. Calibration accuracy should also be assessed, especially for algorithms that provide probabilities to users. As current AI algorithms have limited generalizability to real-world practice, clinical validation of AI should put it to proper external testing and assisting roles. External testing could adopt diagnostic case-control or diagnostic cohort designs. A diagnostic case-control study evaluates the technical validity/accuracy of AI while the latter tests the clinical validity/accuracy of AI in samples representing target patients in real-world clinical scenarios. Ultimate clinical validation of AI requires evaluations of its impact on patient outcomes, referred to as clinical utility, and for which randomized clinical trials are ideal. Device approval of AI is typically granted with proof of technical validity/accuracy and thus does not intend to directly indicate if AI is beneficial for patient care or if it improves patient outcomes. Neither can it categorically address the issue of limited generalizability of AI. After achieving device approval, it is up to medical professionals to determine if the approved AI algorithms are beneficial for real-world patient care. Insurance coverage decisions generally require a demonstration of clinical utility that the use of AI has improved patient outcomes.

• 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.

• 한국융합학회논문지
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• 제11권1호
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• pp.237-246
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• 2020

본 연구의 배경 및 문제는 초경량비행장치 산업의 발전으로 드론의 성능이 향상되고 운행 대수는 증가하는 반면에 비행 인·허가 과정은 개선되지 않아 민원이 증가하는 추세에 있다. 목적은 민원을 최소화하고 양개기관 요구조건에 맞게 시스템 운용 및 관리 전반에 대한 개선이다. 연구방법은 문헌연구 및 조사를 통하여 문제점을 도출하고 기관 및 전문가들의 포커스 그룹 인터뷰를 통해 검증하여 개선안을 제시하였다. 연구결과는 국토부 주관 하 항공안전법 내에 양개기관 임무·역할 및 시스템 운용·관리에 대한 반영, 비행 인·허가에 대한 명칭·절차·양식의 통합, 시스템 상에 홈페이지 바로가기 등 다수의 기능개선이다. 기대효과는 첫째, 관련법령에 양개기관의 임무와 역할을 명시함으로서 민원처리 협조가 원활해지며 둘째, 민원처리 프로세스를 통합함으로서 처리 기간단축으로 효율성이 향상되고 셋째, 대국민서비스 부가기능을 개선함으로서 민원 최소화가 기대된다. 향후 연구는 국방부 주관 하 항공촬영허가에 대한 제도적 기반마련, 국방개혁 2.0연계 관할부대 재편성, 현장 보안조치부대 여건보장 등 개선이 필요하다.

• 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.

• 한국마린엔지니어링학회:학술대회논문집
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• 한국마린엔지니어링학회 2011년도 전기공동학술대회 논문집
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• pp.250-253
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• 2011

The cruise industry is one of the world's fastest growing device industry which is structural construction coasts are expensive. Cruise out-fittings are thirty times compare with general large vessels. According to the characteristics of materials or equipments, most equipments are imported from europe. At present domestic shipbuilding industries and minor enterprises have a hard times therefore enhancing technology for the cruise industry could be infused vitality on the industries. If domestic small and midium industries have high technology for the cruise ship, domestic small and midium industries can have global competitiveness compare with european equipment suppliers which has small-scale and high technology. Therefore on this study, cruise ship's new equipment development and a study for the performance assessment and classification type approval certificate was carried out.

• 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.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1995년도 춘계학술대회
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• pp.21-27
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• 1995

This document collects Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) guidance documents, citations to the primary literature, and other published and unpublished documents relevant to development and approval of drug/device combinations collected by the CDRH Division of Cardiovascular, Respiratory and Neurological Devices (DCRND). Since the Master Bibliography number represents an accession number, an alphabetical (by author) listing appears at the end of the document, Any citation marked with a, is on file in the DCRND offices, 340B, in the Piccard Building (HFZ-450), 1390 Piccard Avenue, Rockville, MD 20850.

• 대한의사협회지
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• 제61권12호
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• pp.765-775
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• 2018

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, 'digital exceptionalism' (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.