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ZHANG Qi, CHEN Min, ZHANG Shiqing.
Conditional approval of medical devices in the United States and enlightenment
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ZHAO Yan, LIU Wenbo, ZHAO Yifei, LI Dong, ZHENG Lijia, SONG Yana, ZHAO Yujuan, DONG Fang.
Applicability of patient registry research to regulation of medical devices
[J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 423-427.
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ZHAO Yan, LI Dong, CHENG Yinjie, JIANG Bin, ZHAO Yifei, DONG Fang, YUAN Jing.
Advances in studies on post-market safety data sources and signal detection for medical devices
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Thoughts on constructing vigilance system of Chinese medical device in the new era
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Progress in the application of real-world data in post-market surveillance of medical devices
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Introduction and inspiration of international medical device regulators forum patient registry guidelines
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Expert consensus on post-marketing risk monitoring technology for high-risk implantable passive medical devices based on real world data
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Implications of Regulatory Science for the Construction of Medical Device Vigilance Systems
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Medical Device Vigilance Systems in European Union
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Practice and Exploration of Uniformity about Medical Device Evaluation Criterion
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JU Shan, LIU Yinghui, WANG Yawen, TENG Yingying, JIANG Yan, DENG Gang, SUN Lei.
Clinical Evaluation of Medical Devices Seen from International Coordination Documents
[J]. Chinese Journal of Pharmacovigilance, 2021, 18(11): 1062-1065.
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Role of Standards in Medical Device Evaluation
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ZHENG Li-jia, ZHAO Yan, DONG Fang.
Research on Medical Device’s Post-marketing Surveillance between China and Japan
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