Risk Management Analysis of Medical Device Registration Self-inspection.
10.3969/j.issn.1671-7104.2023.05.015
- Author:
Yonghong LI
1
;
Jianning ZHU
1
;
Yanxue FANG
1
;
Hua YANG
1
Author Information
1. Center for Inspection of Gansu Medical Products Administration, Lanzhou, 730070.
- Publication Type:Journal Article
- Keywords:
medical device;
registration self-inspection;
risk management
- MeSH:
Risk Management;
Commerce;
Medical Device Legislation
- From:Chinese Journal of Medical Instrumentation
2023;47(5):545-549
- CountryChina
- Language:Chinese
-
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.
