Risk Management Analysis of Medical Device Registration Self-inspection / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
; (6): 545-549, 2023.
Article
in Zh
| WPRIM
| ID: wpr-1010236
Responsible library:
WPRO
ABSTRACT
Through the analysis of laws and policies related to registration self-inspection, visiting and researching enterprises, holding symposiums, and issuing nationwide questionnaires, the risks in the registration self-inspection process were summarized, analyzed, and evaluated. From the aspects of regulatory departments and manufacturing enterprises, we suggest to improve China's medical device registration regulations system and reduce the risks of all parties in the registration self-inspection work.
Key words
Full text:
1
Index:
WPRIM
Main subject:
Risk Management
/
Commerce
/
Medical Device Legislation
Language:
Zh
Journal:
Chinese Journal of Medical Instrumentation
Year:
2023
Type:
Article