의료기기 분야의 아이디어 발상원리 및 효용성에 관한 연구 : IDEA Medical & Health 입상작을 중심으로

연주한,도성정 한국창업학회 2019 한국창업학회지 Vol.14 No.4

최근 의료기기 산업은 사람들의 치료와 건강을 위하여 매우 중요해지고 있으나 의료기기 산업의 발전을 위한 아이디어 발상 원리와 세부적인 고객의 정의에 관한 연구는 매우 부족한 상황이다. 본 연구에서는 의료기기 산업의 아이디어 발상원리와 세부적인 고객을 도출하기 위하여 BCC 사고도구를 이용하여 IDEA 디자인 어워드 medical & health 분야의 5년간의 입상작들을 분석하였다. 또한 의료기기들이 고객에게 어떠한 효용성을 제공하고 있는지를 알아보았다. 그 결과 의료기기 제품들에서도 다른 산업들과 동일하게 속성의존, 결합 코드의 적용빈도가 가장 높게 도출되었으며, 다른 산업과는 다르게 분리코드가 의료기기 제품에서는 활발히 적용되었다. 연구대상인 IDEA 디자인 어워드 의료기기분야의 주요고객으로 의사, 환자, 약사 및 간호사로 도출되었으며 이러한 고객을 위하여 제공하고 있는 효용 지렛대의 요소는 기능성과 사용성으로 도출 되었다. Recently, medical device industry is getting more important for people's cure and health. However, research on detailed customer definition and inventive thinking principle of medical device industry is very limited. Hence, in order to study the principle of inventive thinking principle in the medical device industry, 63 products of the IDEA design award winning for medical & health were analyzed by using BCC (Business Creativity Codes) along with the real customers of the medical device. In addition, we analyzed the utility of medical device that affected customers. The main results of this study are as follows. First, the principles of attribute dependency and combination are most frequently applied in the medical device industry as in other industries. Second, the division principle that is not actively applied in other industries has actively been applied in the medical device industry. These results indicate the characteristics of the medical device industry that require more accurate diagnosis and cure. Third, the major customers of medical device are analyzed to be doctors, patients, pharmacists and nurses. Fourth, the utility levers of medical device were found to be functionality and usability. This result suggests that the medical device industry had better perform activities that improve the functionality and usability of the product for more accurate diagnosis and cure.

일회용 의료기기에 적용을 위한 ISO 14971:2019 분석과 Periodic Safety Update Report 작성 방법 – Medical Device Regulation 2017/745 요구사항 중심으로

박상민,유규하 대한의용생체공학회 2023 의공학회지 Vol.44 No.1

With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management pro- cess basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

우리나라 의료기기 부작용에 따른 피해구제시스템 도입방안 연구

최철호 한국의료법학회 2017 한국의료법학회지 Vol.25 No.2

본 연구에서는 의료기기 사용자에 대해 피해 발생에 대한 원인과 조사방법과 이러한 피해가 오로지 의료기기 부작용으로 인한 피해인지에 대한 규명을 통해 피해구제를 목적으로 하는 것이므로 예방적인 차원에서는 독립적으로 피해구제사업에 대한 모델을 도출하고자 하였다. 이에 따라 의료기기 부작용에 대한 보고체계와는 독립적인 방안으로 피해구제에 있어서 의료기기의 안전성의 문제영역으로 확대하는 제도의 구축과 연계제도를 고안하였다. 의료기기 부작용신고시스템과 관련하여 무과실 피해구제제도의 도입을 연계방안을 모색하였다. 아울러 의료기기 부작용 피해에 대한 구제절차는 일반적인 민사절차 이외에 행정적인 무과실보상제도로서 기금방식, 보험방식 혹은 조정절차로서 ADR 방식(가령 한국의료분쟁조정중재원)을 고려할 수 있지만 기금방식인 부담금제도를 도입하고자 하였다. 또한 의료기기법의 시행과 입법상의 독자성 등으로 인해 의료기기법 관련규정의 용의성을 고려하여 볼 때 가칭 ‘한국의료기기안전관리원’을 설치하는 안이 바람직하다고 판단하였다. 우리나라에서도 의약품의 경우 한국의약품안전관리원이 내부적으로 의료분쟁중재조정원의 절차와 통합하고자 고려하였으나 현재 독립적으로 시행하고 있다. 이러한 점에서 의료기기부작용에 대한 독자적인 피해구제기관의 설립방안을 도출하고 있다. 의료기기업체 측면, 피해자(환자)의 측면, 조직상의 측면에서 의료기기피해보상시스템은 환자중심의 신속한 편익제공, 업무편의성 증대, 기업의 사회적 책임과 새로운 가치창출 이라는 긍정적인 효과를 가져올 수 있도록 하기 위해 이러한 제도를 모델로 소개하면서 의료기기부작용피해구제기관의 설치방안으로 가칭 ‘한국의료기기안전관리원’의 조직, 업무, 구성, 운영 등에 대해 자세한 방안을 제시하였다. 수익자부담원칙에 따른 의료기기회사의 시장지분에 따라 매출액과 의료기기 품목 및 등급에 따라 부담금을 산정하더라도 피해구제기금의 운영방안에서 기업의 부담이 될 수 있다는 우려가 있다. 하지만 영세한 의료기기 업체의 손해배상책임이나 피해금액의 부담 등 기업활동에 오히려 안전장치를 마련할 필요가 있으며, 피해구제기금에 대한 부담금도 피해자의 구제에만 목적사업이 쓰일 수 있도록 한다면 의료기기 업체도 받아들일 수 있으며, 이러한 부작용피해가 발생시 제조사나 허가권자는 보다 적극적인 대응을 할 수 있는 유인책으로 판단된다. The purpose of this study is to investigate the cause and investigation method of damage to medical device users and to identify the damage caused by the adverse effects of medical devices. And to derive the model. Therefore, we have devised a system for establishing and linking a system that extends to the problem of safety of medical devices in damage relief in a way that is independent of the reporting system of medical device side effects. Related system for medical device adverse reaction reporting system. In addition to the general civil procedure, the remedy for damaging the adverse effects of the medical device is the administrative irregular compensation system, which can consider the ADR method (for example, the Korea Mediation Dispute Arbitration Mediator) as the fund method, insurance method or mediation procedure. Also, considering the practicality of the regulations related to the medical devices due to the implementation of the medical device technique and the uniqueness of the legislation, it was considered desirable to establish the so - called 'Korea Medical Device Safety Management Center'. In Korea, the Korean Medicines Safety Authority considers internal medicines to be integrated with the procedures of the mediation arbitrators, but it is currently being implemented independently. In this regard, the establishment of independent damage relief agencies for the adverse effects of medical devices is being sought. In terms of medical device companies, victims (patients), and organizational aspects, the medical device damage compensation system is designed to provide prompt patient-centered benefits, increase work convenience, and bring positive effects to corporate social responsibility and creation of new value. This system was introduced as a model and suggested detailed plans for the organization, operation, organization and operation of the 'Korea Medical Device Safety Management Service' in order to install the medical device side effect damage relief organization. Even if the amount of contribution is calculated according to the sales amount and the medical device item and grade according to the market share of the medical device company in accordance with the principle of beneficiary burden.

의료기기 안전성 정보 모니터링에 대한 한병병원 및 병원 종사자의 인지도 조사연구

김지현,남기창,김호준,남연교,김유진,조은혜,권범선,Kim, Ji Hyun,Nam, Ki Chang,Kim, Hojun,Nam, Yeon Gyo,Kim, You Jin,jo, Eun hye,Kwon, Bum Sun 대한의용생체공학회 2021 의공학회지 Vol.42 No.3

Purpose: The purpose of this study is to find out the cognizance of medical device safety information (MDSI) monitoring in the hospital and oriental hospital workers, and the different aspect of MDSI between oriental medical devices and medical devices. Methods: The survey was performed both in the oriental medicine hospital and general hospital. The survey had 16 items; 2 items basic questions, 5 items in the awareness of MDSI, 5 items in the education of MDSI, 4 items in the necessity of defining oriental medical devices and differences between general and oriental medical devices. A total of 120 hospital worker were participated; 60 oriental medicine hospital workers and 60 general hospital workers. They had worked in the oriental medicine or general hospital associated with 'Medical Device Safety Monitoring Center, Dongguk University Ilsan Hospital' in 2019 and 2020. Results: The cognizance of MDSI was high both in oriental medicine hospital and general hospital workers and there were no significant differences between oriental medicine and general hospital workers. When we divided the hospital workers into the senior workers who had worked for over 3 years and junior workers for less than 3 years, the senior workers had higher awareness of MDSI than junior workers. However, the cognizance of education of MDSI was high which was not different between senior and junior workers. Both hospital workers thought that it was necessary to define oriental medicine device legally and the oriental medical device might have low risk and less side effect than medical device. Conclusion: The cognizance of MDSI was high and there was no significant differences between oriental medicine and general hospital workers. Because the senior hospital workers had higher recognition of MDSI, we need to provide the continuous education program for junior hospital workers. Although oriental medical device are thought to be safer than medical device, we need to have a legal definition.

의료기기분쟁과 분쟁조정제도 ― 독일의 법적 현황을 참고하여 ―

양천수 ( Chun-soo Yang ),우세나 ( Se-na Woo ) 안암법학회 2021 안암 법학 Vol.- No.62

최근 의료기기로 인한 인권침해 등과 같은 의료기기분쟁이 증가하면서 「의료기기법」개정이 검토된다. 오늘날 의료행위에서 의료기기가 차지하는 비중이 높아지면서 의료기기의 결함 문제 및 이로 인해 발생하는 분쟁을 해결하는 것이 중요한 이슈가 된다. 이에 의료기기의 결함으로 발생하는 피해로부터 환자나 이용자를 적절하게 보호할 수 있는 법제를 구축할 필요가 있다. 「의료기기법」개정안은 이러한 문제의식을 고려한 것으로 평가된다. 개정안은 크게 두 가지를 제시한다. 첫째는 제조자의 책임보험 가입을 의무화하는 것이다. 둘째는 분쟁조정제도를 설치하는 것이다. 그러면 이러한 개정안은 타당한가? 이를 검토하기 위해 이 글은 비교법 방법을 원용한다. 특히 이 글은 우리 법체계에 많은 영향을 미친 독일의 법제도, 그중에서도 의료기기의 분쟁조정을 어떻게 규율하는지를 검토한다. 이를 통해 이 글은 다음과 같은 시사점을 획득하였다. 첫째, 독일의료기기법은 의료기기분쟁을 정면에서 규율하는 법적ㆍ제도적 장치는 담고 있지 않다. 둘째, 독일은 우리처럼 의료분쟁을 전담하는 의료분쟁조정법을 갖고 있지 않다. 의료분쟁에 대한 ADR은 민간 주도로 구축되어 있다. 의료조정원이나 감정위원회가 그것이다. 셋째, 의료조정원이나 감정위원회에 대해서는 기본원칙으로 자발성과 비구속성이 적용된다. 넷째, 의료기기분쟁에 대한 ADR로는 독일 조정법에 따른 조정을 언급할 수 있다. 독일 조정법에 의한 조정 역시 철저하게 자율적으로 진행된다. 이 글은 이러한 시사점을 바탕으로 하여 우리의 「의료기기법」개정안을 다음과 같이 평가한다. 우선 책임보험 가입을 의무화하는 개정안은 긍정적으로 평가할 수 있다. 그러나 행정형 분쟁조정제도를 신설하는 것에는 의문을 제기한다. 행정형 분쟁조정제도는 조정의 본래적 취지와 맞지 않는 것으로 보이기 때문이다. 특히 조정을 통해 도출한 합의에 기판력에 준하는 강력한 법적 구속력을 부여하는 것은 문제로 보인다. 물론 그렇다고 해서 법적 구속력을 전적으로 부여하지 않는 것도 바람직하지는 않다. 조정으로 도출한 합의에는 조정제도의 효율성을 제고할 수 있도록 집행력 정도의 법적 구속력을 인정하는 게 적절해 보인다. 아울러 이 글은 법정책적으로는 다음과 같은 방안도 제안한다. 현재 운용 중인 의료분쟁조정제도가 관할하는 대상에 의료기기분쟁을 추가하는 방안이 그것이다. Recently, as medical device disputes such as human rights violations due to medical devices increase, the revision of the Korean 「Medical Devices Act」is being reviewed. As the proportion of medical devices in medical practice today increases, resolving the problem of defects in medical devices and its disputes becomes an important issue. Accordingly, it is necessary to establish a legal system that can adequately protect patients and users from damage caused by defects in medical devices. The amendment to the Korean 「Medical Devices Act」is evaluated to take into account this awareness. The amendment proposes two main things. The first is to oblige the manufacturers of medical devices to buy a liability insurance. The second is to establish a dispute mediation system for the medical device disputes. So, is this amendment valid? To review that question, this article uses the comparative law method. In particular, this article examines the legal system and situation of Germany, which has had a great influence on Korean legal systems, especially how it regulates dispute settlement of medical devices. Through those, this article has obtained the following implications. First, the German 「Medical Devices Act」does not contain legal and institutional mechanisms that govern medical device disputes. Second, German legal systems do not have a medical dispute mediation law dedicated to medical disputes like ours. The ADR on medical disputes is established by the private sector. The ‘Schlichtungsstelle’ or ‘Gutachterkommssion’ are those. Third, ‘Freiwilligkeit’ and ‘Unverbindlichkeit’ are applied as basic principles to the ‘Schlichtungsstelle’ and ‘Gutachterkommssion’. Fourth, the ADR for medical device disputes can refer to the mediation system according to the German mediation law. The mediation under the German mediation law is also ruled by the principle of autonomy. Based on these implications, this article evaluates the amendment of the Korean 「Medical Devices Ac t」as follows. First of all, the amendment which mandates buying a liability insurance can be evaluated positively. However, the establishment of an administrative dispute mediation system should meet questions. This is because the administrative dispute mediation system does not seem to fit the original purpose of the mediation system. In particular, it seems to be a problem to impart a strong legal binding power to agreements reached through a mediation. Of course, the article does not argue that the agreements should have no legal binding power. Instead, it seems appropriate for the author to recognize the legal binding power as executive power to improve the efficiency of the mediation system in agreements reached through a mediation. In addition, this article proposes the following measures for legal policy. This is a propose to add medical device disputes to the subject under the jurisdiction of the medical dispute mediation system currently in operation in Korea.

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.

임상적 관점에서의 의료기기 관리제도 개선방안 연구

김병관 ( Kim Byung-gwan ),양석조 ( Yang Seok-jo ) 한남대학교 과학기술법연구원 2019 과학기술법연구 Vol.25 No.4

의료기기에 대한 임상평가는 의료기기 안전관리를 위한 매우 중요한 규제이다. 그러나 의약품과 달리 잠재적 위해도 차이에 따른 등급 분류, 다양한 시술 환경, 적응증의 구체성 등 의료기기적 특성상 의료기기에 대한 임상적 안전성·유효성을 체계적으로 평가하기 위한 제도는 전 세계적으로도 아직까지 완벽하게 정립되지 않은 실정이다. 특히, 첨단기술의 빠른 발전 및 다양한 신개발의료기기의 등장과 더불어 미국, 유럽 등의 경우 의료기기에 대한 효율적인 임상평가를 위하여 지속적으로 관련 제도를 개선 중에 있음을 고려할 때 우리나라의 경우에도 임상적 관점에서 의료기기 관리제도를 합리적으로 개선할 필요가 있다. 이를 위해 의료기기 등급별 차별화된 임상평가 체계 도입과 다양한 환경에서 수집되는 임상정보를 효과적으로 분석·평가할 수 있는 체계적인 방법이 필요하다. 또한, 의료기기 임상평가에 대한 관점을 의료기기 안전관리제도 전반에 걸쳐 잘 연계될 수 있도록 개선할 필요가 있다. 임상자료 평가체계의 개선을 통해 궁극적으로 의료기기 전주기에 걸친 안전관리 강화 및 미래의료기술 환경에 대한 선제적인 대응 기반을 마련할 수 있을 것으로 기대한다. Clinical evaluation is a very important procedure for the safety and effectiveness management of medical devices. However, unlike the pharmaceutical field, the systematic procedure to assess clinical safety and effectiveness of medical device has not been established due to the characteristics of medical devices such as the class of medical device according to potential risks, various treatment environment, and the specificity of indications in the view of regulatory process. In the United States and Europe, the clinical evaluation system is continuously being improved with the rapid development of advanced technologies and continuous emergence of innovative medical devices. Considering that Korea has not only been struggling to establish the proper clinical evaluation system of medical devices since the introduction of substantial equivalent concept of FDA in 2001 but also is in the same medical device industry environment, it is also highly needed to review the previously introduced clinical evaluation system and to improve it in global regulatory perspective. As a result of comparison to the United States and Europe, Korea will need a differentiated clinical data evaluation system by medical device classes and the method to analyze effectively clinical data collected in more diverse sources such as clinical reviews in the filed of medical technology. The improvement of the clinical evaluation system will ultimately establish an effective clinical data evaluation system throughout the total life cycle of medical devices to be enable interconnecting the pre-market & post-market clinical evaluation system in Korea. It is expected that the safety management of medical devices will be strengthened through the improvement of the clinical evaluation system for medical devices, and that will be able to respond more effectively to the future medical environment.

복지용구사업소 운영 인력의 역할 및 교육훈련의 과제

김정순,강인순,하주영,진영란,이효영 한국직업교육학회 2009 職業 敎育 硏究 Vol.28 No.4

This study was conducted to bring up the role and the appropriate education & training for working personnel of Korean welfare medical device center. We investigated five programs of related with welfare medical device in Korea and Japan. In addition to this, we surveyed the role and the appropriate education & training for working personnel of Korean welfare medical device center with the ideas by experts investigation. The main roles and duties of personnel in welfare medical device center were examined as 'understanding of a target person', 'counselling about using welfare medical device', 'planning comprehensive long-term application of welfare medical device', 'evaluation of service', 'cleaning, disinfecting, and A/S of welfare medical device', 'calculation of the device price under long-term care insurance', and 'delivery & installation of welfare medical devices'. In addition to this, prerequisites to operating a education and training program were issuing certificate of qualification & improving facilities. The appropriate education times were inspected as sixty seven hours(thirty five hours for non-practical education, thirty one hours for practice). Delivering appropriate education program and defining role of welfare medical device center personnel were very important for soft landing of long-term care insurance. 본 연구의 목적은 복지용구 사업소 운영 인력의 역할 업무 범위의 파악과 함께 이들을 위한 교육훈련 과정의 개발을 위한 시사점을 제시하고자 하는 것이다. 이를 위해 복지용구 관련 제도 및 교육과정의 고찰과 전문가 의견조사 및 설문조사 등이 활용되었으며, 본 연구의 결과는 다음과 같다. 복지용구사업소 운영 인력의 역할 및 업무로 대상자에 대한 파악과 이해, 복지용구에 대한 상담, 복지용구 활용계획 수립 및 서비스 평가, 소독 및 유지·보수 등이 핵심 역할로 파악되었다. 또한 복지용구의 표준 인증 및 보험가격의 산정, 복지용구의 설치 및 운반 등도 역시 이들이 해야 하는 역할로 나타났다. 교육훈련 시 가장 필요한 사항 및 선결되어야 하는 과제에 대해서는 관련 자격증의 발급이 가장 필요하다고 하였고, 체험학습 등의 교육시설의 확충이 그 다음으로 높게 나왔다. 적정한 교육시간 평균은 67.3 시간으로 이론 35.6시간, 실기 31.8시간으로 조사되었다. 노인장기요양보험의 성공적 안착을 위해 복지용구사업소 운영 인력의 역할의 정립과 함께 이들의 교육 및 훈련은 매우 중요한 사항으로 제도적인 보완과정이 반드시 뒤따라야 할 것으로 판단된다.

의약품 및 의료기기 생애주기별 국내외 급여 관리제도 비교

윤상헌,박다혜,신서희 건강보험심사평가원 심사평가연구소 2022 연구보고서 Vol.2022 No.0

Background Korean society is aging rapidly and such trend is expected to result in high supply and demand of medicine and medical technology. The phenomenon is likely to lead to increased health expense of the National Health Insurance (NHI) fund, calling for management measures to secure appropriate reimbursement. Against this backdrop, ‘The First Comprehensive Plan of NHI’ has introduced diverse management systems for medicine and medical device, without much success due to conflicts between different programs and purposes. As such, rational and effective adjustment measures are required. Objective This study aimed to systematically and comprehensively review medicine and medical technology management systems on approval, reimbursement, and post management by life cycle. Based on the country comparison and analysis, the results of this study will serve as the baseline data for preemptive system improvement in response to changing health environment. Method This study was largely based on literature review from Korea and abroad as well as consultation of experts in the field. In order to understand current status of reimbursement management systems on medicine and medical technology in Korea and abroad, we analyzed reports of international organizations, papers published in journals, and health-related governmental websites. In addition, interviews took place with professors with expertise and relevant enterprises. Results In this study, the life cycle of a medicine and medical technology consisted of 5 stages: 1) research and development along with regulation and procedure check, 2) approval, 3) manufacture and distribution, 4) NHI coverage listing/reimbursement, and 5) post management. This study consolidated management systems of 7 reference countries (the U.S., the U.K, France, Germany, Italy, Switzerland, Japan) as well as Australia and Canada for full cycle of medicine and medical technology of each country in an organized manner. Conclusion and proposal Korean medicine management system was found to be similar to those of comparison countries with the exceptions of Global Budget and Reference Pricing. There were some confusions coming from use of terminology, as Korea uses differentiated terms such as ‘medical technology’, ‘medical equipment’, and ‘medical device’ depending upon the function, objective, and lifespan of a medicine. Like other reference nations, Korea had systems of phased review, value assessment, and preliminary benefits in place, but it lacked Unique Device Identification (UDI) system for tracking. In regards to medical technology and post management, the level was lower than that of medicine, and reassessment cycle was sparser. The following is suggestions of this study based on such results. First, systematic policy road map and reinforced consumption volume control measures are required. Korea has established and operated medicine management system on par with those of advanced countries, yet systematic inefficiency is an issue as there are hundreds of generic drugs for one medicine. Second, current approval and reimbursement linkage in generic drug pricing system is limited to quality assurance feedback (bioequivalence test, use of registered drug master file), which requires further connection of patient health data of clinical trial. The mechanism should be prepared so that the effective use of approval - reimbursement linkage can be realized. Third, terminology clarification and clean-up is necessary to improve consistency and reduce confusions in the area of approval, reimbursement, and post management. For example in medical technology system, the term ‘medical device’ used for medical supplies covered by NHI could be specified to ‘separately reimbursed medical device’, ‘not separately reimbursed medical device’, and ‘non-benefit medical technology’. Forth, more proactive tracking system is required through revising and reinforcing medical technology and UDI. Fifth, post management of medical device should consider introducing price-volume agreement. Such adoption would require evidence data from suppliers and data transfer system with the review authority, in consideration of both the new products and existing listed products. The objective of reassessment should be clarified as well, whether it should be about management efficiency or cost saving. France’s case could serve as a reference where after a certain period of time from listing, price is adjusted down as the item is categorized as existing group. Sixth, active post management measures should be implemented for high risk medical device, such as adverse drug event reporting system. When the quality is not guaranteed, the item should be subject to elimination from the price list and benefit quality assessment for additional action.

연구논문 : 새로운 과학기술도입과 의료기기 해당성 판단

배현아 ( Hyuna Bae ) 한남대학교 과학기술법연구원 2015 과학기술법연구 Vol.21 No.3

의료기기 해당성 판단은 사람이나 동물에게 단독 또는 조합하여 사용되는 기구·기계·장치·재료 또는 이와 유사한 제품으로서 질병을 진단·치료·경감·처치 또는 예방할 목적으로 사용되는 제품, 상해(傷害) 또는 장애를 진단·치료·경감 또는 보정할 목적으로 사용되는 제품, 구조 또는 기능을 검사·대체 또는 변형할 목적으로 사용되는 제품 그리고 임신을 조절할 목적으로 사용되는 제품으로 정의된 의료기기법과 이에 대한 법원의 해석을 근간으로 이루어진다. 또한 의료기기 해당성 판단은 연구과정과 제조를 위한 인허가, 임상 시험의 필요성, 국민건강보험 제도에서의 체계, 의료광고의 대상 등 이후 보건의료법체계에서의 규제 내용과 그 대상 범위를 결정하는 의의를 가진다. 그러나 의료기기 해당성 판단은 다양하고 전문화 된 생명과학기술과 정보통신 기술 등 과학기술의 발전을 즉각적으로 반영할 수 없는 입법 기술 상의 한계로 인하여 기술발전과 사회의 변화를 고려하여 개별적으로 이루어질 수밖에 없다. 이 때 의료기기 해당성 판단의 ‘목적성’ 에 근간을 둔 일반적인 원칙과 함께 개별 기기의 위험성과 특수성을 고려한 평가가 이루어져야 한다. The Medical Device Act defines the term "medical device" as an instrument, machine, device, material, or any other similar product alone or in combination for human beings or animals such as a product used for the purpose of diagnosing, curing, alleviating, treating, or preventing a disease; a product used for the purpose of diagnosing, curing, alleviating, or correcting an injury or impairment; a product used for the purpose of testing, replacing, or transforming a structure or function; a product used for birth control. To determine whether the Medical Device Act regulates specific use of certain products or devices, the court’s interpretation is required. The applicability of the term "medical device" in Medical Device Act has been developed, interpreted and refined by the rulings of the Supreme Court. Interpreting and, thus, deciding whether the Medical Device Act shall be applied in specific cases plays crucial roles in shaping thescope and subject of the regulation of the medico-legal system; including regulatory approval for developing and producing medical products, clinical trials as well as regulating medical advertisements. The question of whether a device or product shall be regulated as a medical device can only be answered individually taking into account the development of society and technologies because of the inherent limitations on legislative techniques. Legislation cannot spontaneously reflect the rapid development of medical technologies as well as bio-technologies and information technologies. Thus, when deciding applicability of the term “medical device” in certain use of a device or product, one should take the general principle of objective of the law into account as well as risks and peculiarities of individual devices.