Reference and Innovation: Research on the Construction of Medical Device Registrar System.
10.3969/j.issn.1671-7104.2019.03.010
- Author:
Lai XU
1
;
Senyong LIN
1
;
Lijun HU
1
;
Yihan YANG
2
;
Zhong WU
3
;
Jing HUANG
3
;
Haihong JIANG
4
Author Information
1. Shanghai Food and Drug Administration, Shanghai, 200003.
2. Institute of Science and Technology Information, SHFDA, Shanghai, 200233.
3. Management Committee Comprehensive Coordination Bureau, China(Shanghai) Pilot Free Trade Zone, Shanghai, 200135.
4. Shanghai University of Medicine and Health Sciences, Shanghai, 201318.
- Publication Type:Journal Article
- Keywords:
administrative reform;
drug listing license holder;
medical device registrar;
system innovation
- MeSH:
Device Approval;
Industry;
Licensure;
Registries
- From:
Chinese Journal of Medical Instrumentation
2019;43(3):192-196
- CountryChina
- Language:Chinese
-
Abstract:
In order to strengthen the integration of reform system and build a comprehensive integration of openness and innovation, the medical device registrar system has become the institutional choice to promote the reform of the medical approval system and the innovation and development of the industry. The system allows scientific researchers, R&D institutions and enterprises to become applicants for medical device registration and to consign the production of samples and products, thus realizing the separation of market license and production license, and breaking the binding relationship between registration and production in current regulations. The medical device registrar system has laid a theoretical foundation for remolding the management system of medical devices, and has also made practical exploration for improving the reform of the medical devices supervision system, so it has important theoretical and practical significance.
