Reflections on Research and Development Institutions Becoming Medical Device Registrants.
10.3969/j.issn.1671-7104.2023.06.014
- Author:
Xin WANG
1
;
Boxuan GENG
2
;
Haihong JIANG
1
Author Information
1. School of Medical Instruments, Shanghai University of Medicine & Health Sciences, Shanghai, 201318.
2. School of Law, Capital University of Economics and Business, Beijing, 100070.
- Publication Type:Journal Article
- Keywords:
medical device;
medical device registrant;
quality management ability;
research and development institution
- MeSH:
Research;
Certification
- From:
Chinese Journal of Medical Instrumentation
2023;47(6):664-668
- CountryChina
- Language:Chinese
-
Abstract:
As the special subject of the applicant for registration of medical device, the research and development institutions have insufficient conditions and abilities to become medical device registrants, and there are certain difficulties in the actual registration application process, such as not clearing the certification path for the research and development institutions to hold the certificate. In view of the existing problems, by comparing the path of medicine research and development institutions to become medical device registrants and combining with the actual medical device industry to give relevant suggestions, including improving quality management over the whole life cycle of medical devices, quality and safety responsibility ability of research and development institutions, establishing the registration and certification path of research and development institutions, supporting laws and regulations, etc., so as to ensure that the research and development institutions become medical device registrants successfully.
