Study on the Medical Device Registration Submission Dossier Requirements in China.
10.3969/j.issn.1671-7104.2022.04.016
- Author:
Min CHEN
1
;
Chenguang ZHANG
1
;
Yinghui LIU
1
;
Peng YUAN
2
;
Gang DENG
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
2. Nation Medical Products Administration, Beijing, 100037.
- Publication Type:Journal Article
- Keywords:
clinical evaluation;
essential principles;
medical device;
registration;
submission dossier
- MeSH:
China;
Device Approval;
Humans
- From:Chinese Journal of Medical Instrumentation
2022;46(4):428-432
- CountryChina
- Language:Chinese
-
Abstract:
The evolution throughout the whole supervision history of Class II/III safety and effectiveness related NMPA submission dossier requirements was studied in this study, meanwhile elaborating the revolution progress of clinical evaluation domestically. The relationship between submission dossier requirements and Essential Principles of Safety and Performance of Medical Devices as well as IMDRF relevant documents was deeply analyzed and illustrated, in order to comprehensively understanding the background and future reform direction of NMPA submission dossier requirements under the background of the government's deepening reform of medical device evaluation and approval system strategy.
