의료기기 허가⋅신고⋅심사 등에 관한 규정 변화와 전망 : 한의 의료기기 중심으로

김대진,최병희,김태영,정성희,강우석 대한예방한의학회 2024 대한예방한의학회지 Vol.28 No.1

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. 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.

의료기기 진입규제의 변화: 공법적 정당화 논거와 규제 방향성

박정연 숭실대학교 법학연구소 2020 法學論叢 Vol.46 No.-

As innovative technologies such as 3D printing technology, patient-specific precision medical care, big data-based healthcare and artificial intelligence are applied to medical devices, significant changes are being made in medical device regulations. Regulatory authorities continue to improve existing medical device regulations to ensure patient choice and promote new industry developments following technological innovation. However, there is anxiety about whether a series of medical device regulation improvement policies are being progressed based on the principle or limit theory. This paper examines the changes in medical device entry regulations by type, finds the justification from the public view, and suggests the direction for regulatory improvement. Under current law, entry restrictions on medical devices are made through licensing procedures through GMP audits, technical documentation reviews, and clinical trial requirements, as well as new medical technology assessments and health insurance coverage determination procedures. Within this basic structure, various aspects of regulatory changes in medical devices can be classified into low-risk digital healthcare devices, in vitro diagnostic medical devices and newly developed medical devices. In order for current medical device regulatory legislation to be constitutionally justified and improved in the desired direction, individual regulatory legislation and regulatory administration must comply with the proportional principle. In addition, even with high public interest mitigation of entry restrictions, the original regulatory objective of ensuring safety should not be retreated. Furthermore, sufficient information should be provided for consumers to accept the residual risks after risk management. In addition, in order to support industrial development and technological innovation, products must be allowed to enter the market as soon as possible. To do this, regulatory standards must be clear and ensure that no regulatory implications make it impossible to enter the market. 3D 프린팅 기술, 환자맞춤형 정밀의료, 빅데이터 기반 헬스케어, 인공지능 등 혁신적 기술이 의료기기 분야에 도입되면서, 의료기기 규제에 있어서도 괄목할만한 변화가 나타나고 있다. 이 글은 의료기기 진입규제의 변화 모습을 유형별로 구분하여 살펴본 후, 공법적인 시각에서 정당화 근거를 찾고 규제 개선 방향성을 제안하였다. 현행법상 의료기기에 대한 진입규제는 GMP심사, 기술문서심사 및 임상시험 요건 등을 통한 인허가 절차와 신의료기술평가 및 건강보험 수가 결정 절차를 통해 이루어진다. 이러한 기본 구조 속에서 의료기기 규제변화의 다양한 모습은 저위해도 디지털 헬스케어 기기, 체외진단의료기기, 신개발·혁신 의료기기 등에 대한 규제로 구분하여 검토할 수 있다. 지금의 의료기기 진입규제 변화가 헌법적으로 정당화되고 앞으로도 바람직한 방향으로 개선되려면, 규제 입법과 행정이 헌법 제37조 제2항에 따른 원칙에 부합해야 한다. 또한 생명권 보호라는 긴절한 공익적 요청에 따라 진입규제를 완화함에 있어서도 안전성 확보라는 본래의 규제 목적이 후퇴해서는 안된다. 나아가 위험관리 체계를 통해서도 잔존하는 위험에 대해 소비자가 수인할 수 있도록 충분한 위험성 평가와 지속적인 정보제공이 전제되어야 할 것이다. 나아가 산업발전과 기술혁신을 위해서는 제품이 신속히 시장에 진입할 수 있도록 지원해 주어야 하는바, 규제기준을 명확히 하고 관련 규제불비로 인해 시장진입이 불가능한 이른바 (행정)입법부작위 상황이 발생하지 않도록 해야 한다.

의료기기 이상사례 보고에 대한 국내 이해관계자의 관점 차이

이예진,윤치호,최수정,강영준,김진국,권범선,이유경,남기창 대한의용생체공학회 2019 의공학회지 Vol.40 No.5

This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.

동물용 의료기기 기준규격에 대한 고찰

강경묵,김태원,권오륜,박혜정,조수민,김충현,이명헌,문진산,Kang, Kyoung-Mook,Kim, Tae-Won,Kwon, Oh-Ryun,Park, Hea-Jung,Cho, Soo-Min,Kim, Chung-Hyun,Lee, Myoung-Heon,Moon, Jin-San 대한수의학회 2017 大韓獸醫學會誌 Vol.57 No.2

Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.

The Role of Standards in Regulation of Nuclear Medicine Devices

조일성,김경민,김정영 대한방사성의약품학회 2023 Journal of radiopharmaceuticals and molecular prob Vol.9 No.2

Medical devices are products that are directly related to the health of the public. The manufacture, distribution, sale, and aftercare of medical devices are regulated by law. Therefore, medical devices must be manufactured, distributed, sold, and maintained within the scope of the laws and regulations of the country in which they are intended to be used. The International Electrotechnical Commission (IEC) is an international standardization organization that develops standards for the safety of medical devices. The TC 62 subcommittee prepares international standards and other publications that focus on the safety and performance of medical equipment, software, and systems. Countries that dominate the medical device market, such as the United States and Europe, have adopted TC 62 subcommittee standards for medical devices and use them in their regulations. In Korea, the Medical Device Act proves the safety and effectiveness of medical devices and is based on the medical device standards developed by IEC TC 62. For this purpose, medical device developers need to understand regulatory requirements, have the ability to perform verification and certification procedures, and collaborate with regulatory experts to achieve regulatory approval quickly and efficiently. This study aims to identify the requirements for the industrialization of radiation-based medical devices and to identify the standards for regulated medical devices.

최근 유럽연합 의료기기 리스크 법제에 관한 일고찰 : 다주체 간 협업 및 집행구조의 유럽화 현상을 중심으로

이재훈(Jae-Hoon Lee) 유럽헌법학회 2021 유럽헌법연구 Vol.- No.37

2010년 프랑스의 의료기기제조사인 Poly Implant Prothèse가 발암물질을 함유하고 있는 공업용 실리콘으로 체내삽입용 실리콘을 제작하여 판매한 의료기기 스캔들로 인해 유럽연합 차원의 의료기기 법제 전환에 대한 논의가 활발하게 진행되다. 그 결과 2017년 EU의료기기규정이 제정되었으며 2021년 5월 26일에 효력이 발생하였다. EU의료기기규정은 비록 사전배려라는 개념을 직접적으로 사용하고 있지는 않지만 의료기기 제작자에게 UDI 기기식별자 부여, 의료기기 등록 의무 부여, 의료기기와 관련된 리스크 관리 및 품질 관리, 각종 보고 의무 및 관할 당국에의 협력 의무 등을 부과하여 의료기기와 관련된 가치사슬네트워크의 시작 차원에서부터 사전배려적으로 리스크 관리가 이루어지도록 하고 있다. 그리고 의료기기와 관련하여 유럽 전역에서의 조화로운 리스크 관리를 실현하기 위한 제도적 방식으로 유럽연합 집행위원회와 회원국의 관할 당국 간의 긴밀한 협업체계를 도입하고 있다. 유럽연합법의 집행과 관련하여, 유럽연합의 발전에 따라 유럽연합 행정조직 및 각 회원국의 행정조직 간의 협업의 의미는 지속적으로 증가해 왔으며, 이러한 협업의 유형으로는 행정기관 간의 정보 교환, 행정절차 또는 협업을 위해 조직된 별도의 행정조직을 매개로 한 상호 협업 등을 들 수 있다. 그리고 보다 최근에는 이러한 유럽연합 행정기관 및 유럽연합 회원국의 행정기관 간의 협업의 수준을 넘어 보다 체계적이고 제도화 되어 있으며 유럽연합 전역에서 균질적인 유럽연합법 집행을 담보하기 위한 방안으로 행정결정의 내용을 상호 조절하고 경우에 따라서는 계서제와 유사한 수직적 관계를 통해 유럽연합 집행위원회에 의해 회원국 행정청의 결정에 대한 감독 및 통제 가능성이 허용되는 집행구조가 나타나기 시작했다. 이러한 유럽연합의 행정기관과 회원국의 행정기관 간에 수직적·수평적으로 긴밀하게 직조된 집행구조는 ‘유럽연합 행정 결속체’라는 개념을 통해 논의되고 있다. 이러한 맥락에서 EU의료기기규정상 제도들을 살펴본다면, 의료기기 감시체계에서 나타나는 회원국 관할 당국 간 리스크에 대한 상호평가조정절차에서는 전 유럽차원에서 이루어지는 제도화된 정보 교환 협업 체계가 자리 잡고 있음을 확인할 수 있다. 더 나아가 시장감독 차원에서 나타나는 유럽연합 집행위원회에 의한 회원국 관할 당국의 시정조치 검토 및 이에 대한 감독권 행사는 유럽연합차원에서 이루어지는 수평적 상호작용을 넘어 유럽연합 집행위원회가 마치 상급기관인 것과 같은 소위 계서제적 현상이 나타나고 있다고 평가할 수 있다. 이와 같은 EU의료기기규정에서 나타나는 집행구조의 유럽화 현상으로부터 리스크 행정 영역에서도 유럽연합법 집행구조의 유럽화 현상이 나타나고 있다는 점을 발견할 수 있다. In 2010 in EU, discussions on the transition to the Medical Device Regulation were actively underway due to a medical device scandal in which a French medical device manufacturer manufactured and sold silicon for insertion into the body with industrial silicon. As a result, the EU Medical Device Regulation(MDR) was enacted in 2017 and took effect on May 26, 2021. Although the concept of ‘Risikovorsorge’ is not directly used, MDR impose UDI device identifiers, medical device registration obligations, risk management and quality management, various reporting obligations and cooperation obligations with competent authorities. These systems are covered in this paper. In addition, a close cooperative system between the European Commission and the competent authorities of Member States is introduced as an institutional way to realize harmonious risk management across Europe in relation to medical devices. The meaning of collaboration between EU administrative organizations and administrative organizations of each member country has continued to increase with the development of the European Union. More recently, a more systematic, institutionalized and harmonized enforcement of EU law across the European Union has begun, enabling the European Commission to monitor and control decisions of the competent authorities of the Member States through vertical relationships between the European Commission and the competent authorities of the Member States. These vertically and horizontally woven enforcement structures between European Union and Member States are being discussed through the concept of Europäischer Verwaltungsverbund . This paper analyzes these phenomena from the perspective of risk regulation for medical devices.

한방의료기기의 미국 시장 진출을 위한 심사제도 소개

오지윤,최유나,조수정,정찬영,조현석,이승덕,김갑성,김은정 대한침구의학회 2015 대한침구의학회지 Vol.32 No.4

Objectives: The Oriental medical device industry is expected to continue to experience signif- icant 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 de- vices, 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 us- ability, 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.

디지털 치료기기(디지털 치료제) 규제의 이론적 기초와 적용 — 메타규제(Meta-Regulation)의 검토 —

안동인 행정법이론실무학회 2024 행정법연구 Vol.- No.73

우리 사회에서 인구의 급격한 고령화와 그에 수반되는 만성질환의 증가는 큰 사회적 문제가 되고 있다. ICT, 디지털 기술 등의 고도화의 산물인 디지털 치료기기(Digital therapeutics, DTx)는 전통적인 치료법과 구별되는 새로운 혁신적 치료법으로서 위와 같은 사회적 문제에 대응할 수 있는 좋은 선택지가 될 수 있다. 디지털 치료기기는 국민 보건에 관계되는 의료기기로서 엄격한 규제의 대상이 되면서도 그 특성상 전통적인 규범적 규제가 적절하지 않은 대상이기도 하다. 이에 대하여 규제환경의 변화에 대응하기 위하여 새롭게 대두된 규제체계 내지 규제방식으로서 메타규제(Meta-Regulation)의 적용을 검토해 볼 필요가 있다. 메타규제는 통제 중심으로 작용하는 전통적인 결과 지향의 규범적 규제와는 구별되는 과정 지향의 협력적 규제라 할 수 있다. 메타규제는 규제방법에 대한 재량권을 피규제자에게 상당 부분 이양한다는 점에서 자율규제와 유사한 부분이 있으나, 규제기관이 여전히 통제권을 유지한 채 규제대상으로 하여금 스스로 문제를 해결하도록 유도하고 규칙을 만들도록 권장하거나 의무화한다는 점에서 자율규제와 구별된다. 이러한 점에서 메타규제는 강제된 자율규제(enforced self-regulation)라고 평가할 수 있다. 디지털 치료기기 산업은 현대 사회의 대표적인 기술 주도의 신산업이라는 점에서 규제대상인 피규제자가 스스로 어느 정도 규제의 주도권을 지니고 규제체계를 구축해 나갈 필요가 있다. 이와 관련하여 Digital Therapeutics Alliance(DTA)가 제시하고 있는 기본원칙, 모범 실천 사례 및 윤리강령 등은 피규제자가 규제체계를 정립함에 있어 참고할 수 있는 바탕이 될 수 있을 것으로 생각된다. In our society, the rapid aging of the population and the accompanying increase in chronic diseases are becoming significant social issues. Digital therapeutics(DTx), a product of advanced ICT and digital technology, represent a new and innovative therapeutic approach distinct from traditional treatments. They can serve as promising options to address the social issues mentioned above. DTx, as medical devices related to public health, are subject to strict regulation, yet due to their inherent characteristics, they are also not suitable for traditional normative regulation. Therefore, in response to changes in regulatory environments, it is necessary to consider the application of meta-regulation as a newly emerging regulatory system or approach. Meta-regulation can be described as a process-oriented cooperative regulation, distinct from the traditional outcome-oriented normative regulation centered around control. It shares similarities with self-regulation in that it delegates a significant portion of discretion regarding regulatory methods to the regulated entities. However, it is distinct from self-regulation in that regulatory authorities still maintain control, directing regulated entities to solve problems themselves and encouraging or obligating them to create rules. In this respect, meta-regulation can be assessed as enforced self-regulation. Given that the DTx industry represents a leading technology-driven emerging sector of modern society, regulated entities need to take on a certain level of regulatory leadership and contribute to the establishment of a regulatory framework. In this regard, the core principles, best practices, and code of ethics presented by the Digital Therapeutics Alliance(DTA) could serve as valuable references for regulated entities in establishing regulatory frameworks.

3D 프린팅 기술의 의료기기 수리 적용에 대한 국내 규제 이슈 및 기술적 적합성 평가

윤성욱,남경원,Yun, Sung Uk,Nam, Kyoung Won 대한의용생체공학회 2020 의공학회지 Vol.41 No.2

In large-scale hospitals, the department of biomedical engineering should always provide quick repair service for damaged medical devices to guarantee continuous patient treatment. However, in actual circumstances, there are so many time-consuming issues that delays device repair for weeks or even months; therefore, it is required to prepare alternative ways for quick repair service. In this study, we first mentioned about the regulation issues in Korea about the 3D printing-based medical device repair, and then introduced the results of our preliminary study that evaluated the feasibility of 3D printing-based medical device repair before real-field application. Results of the study demonstrated that, in all of the 23 cases, parts for repair that were manufactured by 3D-printing were successfully fixed and connected to the main body of the original device, and showed sufficient rigidity for protecting internal parts of the device. Considering the experimental results, medical device repair by applying 3D printing technology can be a promising alternative in cases when regular repair process is not available or takes too much time.

치의학분야 3D 프린팅 기술이 적용된 의료기기의 인·허가전략과 과제

신은미(Eun Mi Shin),양승민(Seung-Min Yang) 대한치과의사협회 2018 대한치과의사협회지 Vol.56 No.9

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.