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ZHANG Qi, CHEN Min, ZHANG Shiqing.
Conditional approval of medical devices in the United States and enlightenment
[J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 1007-1010.
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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
[J]. Chinese Journal of Pharmacovigilance, 2023, 20(2): 236-240.
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ZHAO Yan, LI Yao, SONG Ya’na, ZHENG Lijia, LI Dong, ZHAO Yifei, BIAN Rongrong, DONG Fang.
Post-marketing active monitoring of medical devices under vigilance
[J]. Chinese Journal of Pharmacovigilance, 2023, 20(12): 1385-1390.
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SHEN Chuanyong, SONG Yana, ZHAO Yan, ZHENG Lijia, ZHAO Yifei, LI Dong.
Thoughts on constructing vigilance system of Chinese medical device in the new era
[J]. Chinese Journal of Pharmacovigilance, 2022, 19(7): 697-701.
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TENG Yingying, LI Chaiquan, XU Yang, TANG Xun, GAO Pei.
Progress in the application of real-world data in post-market surveillance of medical devices
[J]. Chinese Journal of Pharmacovigilance, 2022, 19(3): 233-238.
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SONG Mingyue, ZHANG Ran, WU Zhiang.
Influencing factors of quality risk management of drug recall in China
[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1087-1090.
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ZHAO Yifei, ZHAO Yan, DONG Fang, ZHENG Lijia, LI Dong, SONG Yana.
Introduction and inspiration of international medical device regulators forum patient registry guidelines
[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1091-1096.
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TAN Jing, LIU Chunrong, HUANG Shiyao, GAO Pei, WANG Yang, LI Chen, HE Yong, YUAN Hong, WANG Wen, LI Ling, XIONG Yiquan, REN Yan, YAO Minghong, ZHAO Yan, DONG Fang, SHEN Chuanyong, SUN Xin.
Expert consensus on post-marketing risk monitoring technology for high-risk implantable passive medical devices based on real world data
[J]. Chinese Journal of Pharmacovigilance, 2022, 19(1): 13-17.
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ZHENG Chao, WU Yan, ZHANG Lan, HU Kai, ZENG Ye, WANG Wen, WANG Ling.
Methods for risk trend analysis of EU post-marketing surveillance for medical devices
[J]. Chinese Journal of Pharmacovigilance, 2022, 19(1): 79-82.
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MAO Zhenbin, LIU Shuyu.
Implications of Regulatory Science for the Construction of Medical Device Vigilance Systems
[J]. Chinese Journal of Pharmacovigilance, 2021, 18(7): 601-605.
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ZHAO Yan, ZHAO Yifei△, ZHENG Lijia, DONG Fang.
Medical Device Vigilance Systems in European Union
[J]. Chinese Journal of Pharmacovigilance, 2021, 18(6): 566-569.
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ZHANG Shiqing, WANG Yingjun.
Practice and Exploration of Uniformity about Medical Device Evaluation Criterion
[J]. Chinese Journal of Pharmacovigilance, 2021, 18(11): 1001-1003.
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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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ZHANG Shiqing, ZHANG Xingdong.
Role of Standards in Medical Device Evaluation
[J]. Chinese Journal of Pharmacovigilance, 2021, 18(1): 1-3.
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