CAJ | 학술논문

该文从政府监管的角度出发，探讨构建血液透析装置上市后风险分析方法。通过对国内血液透析装置使用现状提出可操作性的上市后风险识别和上市后风险估计研究方法，为监管部门开展血液透析装置风险管理工作提供技术指导，也为生产企业开展产品上市后风险评价提供参考。
해문종정부감관적각도출발，탐토구건혈액투석장치상시후풍험분석방법。통과대국내혈액투석장치사용현상제출가조작성적상시후풍험식별화상시후풍험고계연구방법，위감관부문개전혈액투석장치풍험관리공작제공기술지도，야위생산기업개전산품상시후풍험평개제공삼고。
This paper discussed the building of post market risk analysis method in hemodialysis device from the point of government supervision. By proposing practical research methods for post market risk identification and estimation on hemodialysis device, providing technical guidance for government to put risk management of hemodialysis device into effect, and offering reference for enterprises to carry out post market risk evaluation on their products as wel.