首页|医疗器械十五项审评制度概述

医疗器械十五项审评制度概述

扫码查看
国家药品监督管理局医疗器械技术审评中心聚焦深化医疗器械审评审批制度改革要求,牢牢把握高质量发展的首要任务,充分研究政务服务信息化、业务流程、资源分配、审评效率、过程管控、科学审评等多方面需求,创造性构建了十五项审评制度,并在此基础上,将质量管理与制度优化紧密结合,探索形成医疗器械审评质量管理体系这一监管新工具,在制度改革过程中深入落实审评科学,助推产业创新高质量发展.
Overview of the Fifteen Reform Systems of Evaluation for Medical Devices
Based on the relevant requirements of the reform for evaluation and approval system,CMDE focused on the mission of the high-quality development,and constructed fifteen reform systems of evaluation creatively.The fifteen reform systems of evaluation took into full account of electronization of government service,business processes,allocation of the resources,efficiency of the evaluation,process control,scientific evaluation.On this basis,CMDE combined quality management with system optimization and established the quality management system of evaluation exploratively.The quality management system of evaluation will implement scientific evaluation,and promot high-quality development of the industry in the process of institutional reform.

Medical deviceTechnical evaluationReform of the evaluation and approval systemQuality management system of e-valuation

李思、仉琪

展开 >

国家药品监督管理局医疗器械技术审评中心,北京 100081

医疗器械 技术审评 审评审批制度改革 审评质量管理体系

2024

中国药物评价
国家食品药品监督管理局信息中心

中国药物评价

影响因子:1.09
ISSN:2095-3593
年,卷(期):2024.41(1)
  • 24