关键词: 医疗器械, 技术审评, 审评审批制度改革, 审评质量管理体系

Abstract: 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.

Key words: Medical device, Technical evaluation, Reform of the evaluation and approval system, Quality management system of evaluation