Analysis on Work Idea of Medical Device Classification Dynamic Adjustment Mechanism in the United States.
10.3969/j.issn.1671-7104.2021.03.018
- Author:
Chunqing ZHANG
1
;
Liangbin ZHOU
2
;
Yue WANG
1
;
Li TIAN
1
;
Xinhua YU
1
;
Xiongfei JI
3
;
Hui ZHANG
1
Author Information
1. NationalInstitutes for Food and Drug Control, Beijing, 100050.
2. Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, 510663.
3. National Center of Standards Evaluation, SAMR, Beijing, 100088. E-mail:zhanghui@nifdc.org.cn.
- Publication Type:Journal Article
- Keywords:
adjustment mechanism;
classification;
medical devices;
risk analysis
- MeSH:
China;
United States;
United States Food and Drug Administration
- From:
Chinese Journal of Medical Instrumentation
2021;45(3):315-320
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:Discuss the working ideas of the dynamic adjustment mechanism of medical device classification in the United States, and provide reference for the construction of medical device related mechanisms in China.
METHODS:Collect and interpret the documents of regulatory background, procedures and orders of the dynamic adjustment mechanism of the medical device classification in the United States, and summarize the overall situation and specific cases of the medical device classification adjustment under this mechanism in recent years.
RESULTS:The US work idea of the medical device classification dynamic adjustment mechanism is based on the latest valid scientific evidence, conducting risk analysis and identification, and determining the corresponding measures.
CONCLUSIONS:During the adjustment process, industry stakeholders have repeatedly discussed and achieved final agreement. Its procedures and working ideas can be used as a reference for China's work.
