Concerns of Technical Evaluation on Registration of Disposable Endoscopic Injection Needle.
10.3969/j.issn.1671-7104.2023.03.017
- Author:
Qingfeng LUO
1
;
Jie LI
1
;
Haiyan XU
2
;
Wei WANG
3
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
2. GBA Center for Medical Device Evaluation and Inspection, NMPA, Shenzhen, 518045.
3. Shanghai Institute of Medical Device Testing, Shanghai, 201318.
- Publication Type:Journal Article
- Keywords:
endoscopic injection needle;
medical device registration and administration;
technical evaluation
- MeSH:
Needles;
Endoscopy;
Injections;
Risk Management;
Industry
- From:
Chinese Journal of Medical Instrumentation
2023;47(3):317-319
- CountryChina
- Language:Chinese
-
Abstract:
From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.
