Center for Medical Device Evaluation. NMPA, Beijing 100076, China
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History+
Received
Published
2024-10-28
2025-03-20
Issue Date
2025-05-27
Abstract
Objective: To analyze the public disclosure data of innovative medical devices released on the official website of the CMDE from 2014 to August 2024, and to provide reference for colleagues in the medical industry. Methods: Through combing and analyzing the application pass rate, regional distribution and type distribution since 2014, the change trend and common problems were analyzed from the perspective of review, as well as relevant suggestions were put forward. Results: It was found that a total of 535 medical devices were approved into the innovation review process, with a pass rate of 19.25%. Most of the medical devices included in the innovation channel are active and passive products, which are mostly concentrated in the high-end fields with high technical content and urgent clinical needs, most of the applicants are concentrated in Beijing, Shanghai, Guangdong, Jiangsu, Zhejiang 5 regions. The common problems in the volume review process mainly focus on the application form, invention patent, and research and development data. There are many problems in each review requirement in the expert review process. Conclusion: It is suggested that enterprises should pay attention to the training of registered personnel and strengthen the study of relevant laws and regulations, and the regulatory authorities should strengthen the cooperation of all units, and do a good job in the relevant training of evaluation experts and applicants.
Zhao Nana, Li Xuejiao. , {{custom_author.name_en}}et al.
Analysis of the Special Review of Innovative Medical Devices in China[J]. Chinese Pharmaceutical Affairs, 2025, 39(3): 300-305 https://doi.org/10.16153/j.1002-7777.2024-10-0050