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Analysis and comparisons for differences with registration submission dossiers for medical devices in China, European Union and Canada
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Chaonan Wang1, Qiang Fu2, *
Modern Instruments & Medical Treatment | 2025, 31(1) : 32 - 36
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Modern Instruments & Medical Treatment | 2025, 31(1): 32-36
Analysis and comparisons for differences with registration submission dossiers for medical devices in China, European Union and Canada
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Chaonan Wang1, Qiang Fu2, *
Affiliations
  • 1.School of Management, University of Shanghai for Science and Technology, Shanghai 200093, China
  • 2.Shanghai Institute of Medical Device Testing, Shanghai 200318, China
Published: 2025-02-10 doi: 10.11876/mimt202501006
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This article introduces and discusses on analysis of the differences for Registration Submission Dossiers for Medical Devices (excluding innovation products) in China、European Union and Canada, Analysis and comparison of differences in Registration Submission Dossiers. Through comparison and analysis of differences, although the focus of medical device registration processes varies in different countries, but according to its medical device management system, submitting Registration Submission Dossiers strictly per relevant requirements which ensure the safety and effectiveness of the marketed products.

Registration submission dossiers  /  Basic principles for safety and performance of medical devices  /  Medical device product classification  /  CMDE guidance  /  CE technical documentation
王超楠, 付强. 中国、欧盟和加拿大医疗器械注册申报资料差异对比及分析. 现代仪器与医疗, 2025 , 31 (1) : 32 -36 . DOI: 10.11876/mimt202501006
Chaonan Wang, Qiang Fu. Analysis and comparisons for differences with registration submission dossiers for medical devices in China, European Union and Canada[J]. Modern Instruments & Medical Treatment, 2025 , 31 (1) : 32 -36 . DOI: 10.11876/mimt202501006
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Year 2025 volume 31 Issue 1
67
9
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doi: 10.11876/mimt202501006
  • Online Date：2026-10-23
  • Published：2025-02-10
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Affiliations
    1.School of Management, University of Shanghai for Science and Technology, Shanghai 200093, China
    2.Shanghai Institute of Medical Device Testing, Shanghai 200318, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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