Regulatory Consideration for Animal Study of Medical Device.
10.3969/j.issn.1671-7104.2023.04.014
- Author:
Maobo CHENG
1
;
Wenbo LIU
1
;
Jiazhen ZHANG
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
animal study;
design;
medical device;
quality;
reduction;
refinement;
replacement
- MeSH:
Animals;
Equipment and Supplies;
Models, Animal
- From:
Chinese Journal of Medical Instrumentation
2023;47(4):428-432
- CountryChina
- Language:Chinese
-
Abstract:
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.
