CHENG Maobo, LIU Wenbo, ZHANG Jiazhen. Regulatory Consideration for Animal Study of Medical Device[J]. Chinese Journal of Medical Instrumentation, 2023, 47(4): 428-432. DOI: 10.3969/j.issn.1671-7104.2023.04.014
Citation:
CHENG Maobo, LIU Wenbo, ZHANG Jiazhen. Regulatory Consideration for Animal Study of Medical Device[J]. Chinese Journal of Medical Instrumentation, 2023, 47(4): 428-432. DOI: 10.3969/j.issn.1671-7104.2023.04.014
CHENG Maobo, LIU Wenbo, ZHANG Jiazhen. Regulatory Consideration for Animal Study of Medical Device[J]. Chinese Journal of Medical Instrumentation, 2023, 47(4): 428-432. DOI: 10.3969/j.issn.1671-7104.2023.04.014
Citation:
CHENG Maobo, LIU Wenbo, ZHANG Jiazhen. Regulatory Consideration for Animal Study of Medical Device[J]. Chinese Journal of Medical Instrumentation, 2023, 47(4): 428-432. DOI: 10.3969/j.issn.1671-7104.2023.04.014
Regulatory Consideration for Animal Study of Medical Device
Animal study plays a key role to evaluate the safety and effectivity of medical devices. This study aims to share evaluated consideration on the role, general principles, necessity, study design and quality management system of animal study, in order to improve the quality of animal study and reduce unnecessary study.
DownLoad: