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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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LI Xinxu, TANG Zhimin, ZHOU Jun, TAN Mingmin, LU Mingliang, WANG Jingzhao, WANG Jun.
Common questions about statistics in communication between drug sponsors and regulators in China
[J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 169-175.
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SHA Mingquan, LI Nannan, XIA Wenjing, WEI Qun, WEN Baoshu.
Research and reflection on regulatory science developments of U.S. FDA
[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1055-1059.
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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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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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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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ZHANG Chen-guang,LIU Yan,XU Wei.
Research and Countermeasure for Information Safety of Intelligent Medical Devices
[J]. Chinese Journal of Pharmacovigilance, 2015, 12(6): 363-365.
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LIN Ni, JIN Hong-tao, WANG Ai-ping.
Progress in Safety Evaluation and Usage of Plasticizers in Medical Devices
[J]. Chinese Journal of Pharmacovigilance, 2014, 11(2): 100-103.
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Li Yu-ji ,SHI Yu-qing .
Analysis of Adverse Event Reports of Surgicel in MAUDE Database
[J]. Chinese Journal of Pharmacovigilance, 2013, 10(5): 312-314.
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KONG Xiang -hong ,ZHANG Wei –hua, YAN Ting –ting.
Analysis of 1059 Suspected Medical Device Adverse Event Reports
[J]. Chinese Journal of Pharmacovigilance, 2013, 10(4): 232-234.
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YANG Peng-fei, JIA Jian-xiong, LIU Bao-lin.
Present Standards and Regulation of Pediatric Medical Devices in China and USA
[J]. Chinese Journal of Pharmacovigilance, 2012, 9(9): 528-531.
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XU Wei.
Discussion on the Industry Innovation from the Status Quo of Medical Devices Registration
[J]. Chinese Journal of Pharmacovigilance, 2011, 8(5): 284-286.
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CHEN Yong-qiang.
Analysis of EU 2009 Edition “GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM”
[J]. Chinese Journal of Pharmacovigilance, 2011, 8(1): 29-31.
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CHEN Ai-min, YANG Tao.
Discussion on the Investigation Mechanism of Serious Adverse Events of Medical Devices
[J]. Chinese Journal of Pharmacovigilance, 2010, 7(3): 178-180.
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