Exploration of Application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices:Take Artificial Joint Products as Example
10.3969/j.issn.1671-7104.230072
- VernacularTitle:《医疗器械安全和性能的基本原则》的应用探讨:以关节假体产品为例
- Author:
Jiayi SUN
1
;
Xinli SHI
;
Shiqing ZHANG
Author Information
1. 国家药品监督管理局医疗器械技术审评中心,北京市,100081
- Keywords:
artificial joint;
quality management system;
risk management system;
safety and effectiveness;
medical device registration information
- From:
Chinese Journal of Medical Instrumentation
2024;48(1):80-84
- CountryChina
- Language:Chinese
-
Abstract:
Through the effective application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices(EP),to continuously improve the corresponding management tools to ensure the safety and effectiveness of medical device in the quality management system,risk management system,evaluation of safety and effectiveness for the supervision departments and manufacturers.The current status of the application of EP and the application issues are analyzed in the study.Take artificial joint products for example,the idea of using EP in quality management system,risk management system and evaluation of safety and effectiveness is investigated,and several thoughts are proposed.Supervision departments should strengthen the unified understanding of EP,develop requirements according to the classification of medical device,and refine specific execution requirements.
