Comparative study on the registration management systems of innovative medical devices in China and the United States
10.3760/cma.j.cn113565-20240327-00088
- VernacularTitle:中美创新医疗器械注册管理体系比较研究
- Author:
Qianqian ZHAO
1
;
Keyu CHEN
;
Ziyan MENG
;
Runping MA
;
Qiufan SUN
;
Lewen FU
;
Zekun LIU
;
Longping YANG
;
Qing LI
Author Information
1. 中国医学科学院/北京协和医学院卫生健康管理政策学院 100730
- Keywords:
Innovative medical devices;
Breakthrough devices;
Registration approval;
Comparative studies
- From:
Chinese Journal of Medical Science Research Management
2024;37(5):434-440
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This article analyzed the current situation, similarities and differences and main problems of the registration and management systems of innovative medical devices in China and the United States.Methods:This article summarized the requirements and policies for the registration management of innovative medical devices in China and the United States, as well as the development and differences of the registration of innovative medical devices in China and the United States, and the main problems in the registration management of innovative medical devices in China.Results:At present, the development level of medical device industry in China and the United States was different, facing different development problems, and there were differences in the access standards and management methods of innovative medical devices. The registration management system established for innovative medical devices in China was gradually improving, and to a certain extent, it had promoted the enthusiasm of innovative product research and development and registration applications, but there were also problems such as unclear innovation evaluation scales, insufficient early intervention of review resources, and insufficient utilization of post-marketing data.Conclusions:Drawing on the beneficial experience of breakthrough device registration management in the United States, we will improve the registration management system for innovative products and shorten the review and approval cycle by clarifying the identification criteria for innovative medical devices, promoting the placement of review resources in the R&D stage, and further strengthening the use of post-marketing data and regulatory scientific research.
