中美欧医疗器械审批上市对比分析——以传统超声影像诊断设备为例

Pre-market Compliance Approval Comparation Among China, USA and Europe Union:Ultrasound Diagnostic Device as An Example

医疗器械产品直接影响人体的健康,各国都建立了复杂而庞大的医疗器械法规体系,从而确保医疗器械的安全和有效,这也使医疗器械的上市过程变得非常复杂。本文以传统超声影像诊断设备为例,从医疗器械的分类、测试、临床评价、体系和周期等五个方面全方位详细分析了中国、美国和欧盟产品审批上市的相同点和差异,剖析了产品在上市过程中最核心的环节,最后分析了我国医疗器械产品上市过程中的瓶颈问题,并给出了相应的建议。

The medical device directly benefits and affects health. Most of countries have established a complex and huge medical device regulation system, so that to ensure the safety and effectiveness of medical device. And it leads to the process of medical device pre-market approval become very complicated. We took ultrasonic diagnosis device as an example, analyzed the similarities and differences among China, the United States and the European Union from five aspects, including the classification, typing test, clinical evaluation, quality management system and pre-market approval cycle time of medical devices. It analyzed the most key points of the device pre-market approval process. And at last the bottleneck in the pre-market approval process for medical devices specific in China was analyzed, also the corresponding suggestions were provided.