Pre-market Compliance Approval Comparation Among China, USA and Europe Union:
Ultrasound Diagnostic Device as An Example
WU Yalan1, JIANG Haihong2,3, ZHANG Peiming2,3
1. Shanghai Landlink Medical Information Technology Co., Ltd, Shanghai 200072, China;
2. School of Medical Instruments, Shanghai University of Medicine＆Health Sciences, Shanghai 201318, China;
3. China Medical Device Policy and Safety Evaluation Center, Shanghai 201318, China
Abstract：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.
武亚兰1，蒋海洪2,3，张培茗2,3. 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[J]. 中国医疗设备, 2019, 34(10): 172-176.
WU Yalan1, JIANG Haihong2,3, ZHANG Peiming2,3. Pre-market Compliance Approval Comparation Among China, USA and Europe Union:
Ultrasound Diagnostic Device as An Example. China Medical Devices, 2019, 34(10): 172-176.
