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KMID : 0986720170250020049
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Korean Journal of Medicine and Law
2017 Volume.25 No. 2 p.49 ~ p.77
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Study on damage remedy system according to medical device side effect in Korea
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Choi Chol-Ho
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Abstract
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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.
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KEYWORD
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Medical device side effects, irregular damage relief system, medical device damage compensation system, charge system, Korea medical device safety management
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