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广西医疗器械审评改革的现状分析与思考

Analysis and Reflection on the Current Situation of Medical DeviceEvaluation Reform in Guangxi Province
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摘要 本研究旨在分析探讨广西区医疗器械审评审批的管理模式。通过回顾分析近三年广西医疗器械审评情况,分析存在问题及其原因。同时,根据广西医疗器械审评改革的现状,提出相关的解决办法和建议。建议审评部门逐步完善并推行咨询管理制度等服务措施,大力支持医疗器械行业人才的培养,为医疗器械产业发展助力。 This study aimed to analyze and discuss the management mode of medical device examination and approval in Guangxi. The problems and their causes were analyzed by reviewing the medical device evaluation in guangxi in recent three years. At the same time, according to the current situation of guangxi medical device evaluation reform, relevant solutions and suggestions were put forward. It is suggested that the evaluation department should gradually improve and implement consulting management system and other service measures, vigorously support the training of medical device industry talents, and facilitate the development of medical device industry.
作者 卢静 曾立威 梁国泉 韦广辉 LU Jing;ZENG Liwei;LIANG Guoquan;WEI Guanghui(Guangxi Food and Drug Evaluation & Inspection Center ,Nanning Guangxi 530029,China;Guangxi Food and Drug Administration,Nanning Guangxi 530029,China)
出处 《中国医疗设备》 2019年第3期143-145,163,共4页 China Medical Devices
基金 广西壮族自治区本级食品药品安全科研项目基金[桂食药科2017-01(直报)]
关键词 医疗器械 医疗器械审评 医疗器械查验 医疗器械产品申报 medical apparatus and instruments medical device evaluation medical device inspection declaration of medical device products
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