省级技术审评机构医疗器械审评模式研究

Study on Medical Device Evaluation Mode of Provincial Technical Evaluation Institutions

创新、优化审评模式有助于提升医疗器械审评质效。该文对广东省等全国20个省、直辖市的医疗器械审评模式进行调查研究,对省级医疗器械审评模式现状及存在的问题进行探讨和总结,为省级审评机构医疗器械审评模式的建立和完善提供意见和建议,同时为深化审评审批制度改革提供参考依据。

Innovation and optimization of the evaluation mode is conducive to improving the quality and efficiency of medical device evaluation.In this paper,the establishment of the medical device evaluation mode in Guangdong Province and other 19 provinces and municipalities directly under the Central Government was summarized and analyzed,and the current status and existing problems of the provincial medical device evaluation mode were discussed and summarized.It provides opinions and suggestions for the establishment and improvement of the medical device evaluation mode for provincial evaluation institutions,and provides reference for deepening the reform of the evaluation and approval system.