의료기기의 시판 후 안전관리 및 실사용 데이터 기반 환자 등록 연구를 위한 「의료기기법」법적 근거 고려사항 도출

초록

Real world Data based patient-registry studies for post-marketing safety control are becoming increasingly important to ensure patient safety and the safety and effectiveness of medical devices by reflecting the characteristics of the actual clinical environment. In Korea, a post-marketing safety control system (re-evaluation, re-examination, medical devices subject to tracking and control, adverse event reporting) is being implemented based on the「Medical Devices Act」. The systems are implemented under the lead of the government for the purpose of public safety by analyzing and evaluating safety information such as side effects that occur while using medical devices on the market. However, patient –registry studies for medical device safety control that integrate clinical information, including patient characteristics and health outcomes, and real world data (UDI, medical device’s characteristics, safety and effectiveness real world data) of medical devices are insufficient. Therefore, the purpose of this study is to propose the necessity of establishing a government-led registry that can conduct patient-registry study for safety control after marketing through comparative analysis of related laws in Korea and the US. In this regard, the US and Europe established a post-marketing safety control study environment under the lead of the government in the form of data networks such as DARWINEU and NESTcc. Using the data obtained from them, post-marketing safety control study is being conducted, On the other hand, in Korea, private led registry based patient-registry studies such as associations and manufacturers for medical technology evaluation are being conducted in terms of health insurance. In addition, the purpose of adverse events reporting stipulated in the「Regulations on Safety Information Management (Side Effects of Medical Devices)」is limited to manual reporting by medical staff, patients, and manufacturers in the event of a problem. As a result of analyzing relevant laws and regulations for post-marketing safety control and patient-registry study in Korea and the US, this study proposed the considerations, including the scope, management subjects, and procedures for establishing a regulatory registry, needed to the「Medical Devices Act」. Th e results of th is study are expected to be used to prepare legal grounds that need to be added to the Medical Devices Act in the future for post marketing safety control of medical devices and patient-registry study.

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