江苏省医疗器械产品技术审评现状分析及改进建议
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摘要
目的:了解江苏省医疗器械行业申报产品状况、审评机构状态和发展趋势,为完善江苏省医疗器械产品技术审评工作提供参考。方法:对2012~2015年江苏省所有受理的8019个医疗器械产品资料的属性、年代分布、产品分布和审评机构人员情况进行统计学分析。结果:产业规模高速发展,而技术审评体系与产业发展速度不匹配。结论:建议江苏省应对现有医疗器械技术审评制度和人员结构进行改进。
Objective:To analyze the status of evaluation institution and registration of medical device industry in Jiangsu province,in order to provide the guidance for critical review of medical devices in Jiangsu province.Method:Through a statistics on 8019 medical device information cases,analysis of attribute date,year distribution and personnel condition in evaluation institution.Result:Technical evaluation system does not match the industry development speed.Conclusion:Suggestions to improve the existing medical devices technical evaluation system and personnel structure of Jiangsu province.
Objective:To analyze the status of evaluation institution and registration of medical device industry in Jiangsu province,in order to provide the guidance for critical review of medical devices in Jiangsu province.Method:Through a statistics on 8019 medical device information cases,analysis of attribute date,year distribution and personnel condition in evaluation institution.Result:Technical evaluation system does not match the industry development speed.Conclusion:Suggestions to improve the existing medical devices technical evaluation system and personnel structure of Jiangsu province.
引文
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