[Concerns of Technical Evaluation on Registration of Disposable Endoscopic Injection Needle]

Qingfeng Luo; Jie Li; Haiyan Xu; Wei Wang

doi:10.3969/j.issn.1671-7104.2023.03.017

[Concerns of Technical Evaluation on Registration of Disposable Endoscopic Injection Needle]

Zhongguo Yi Liao Qi Xie Za Zhi. 2023 May 30;47(3):317-319. doi: 10.3969/j.issn.1671-7104.2023.03.017.

[Article in Chinese]

Authors

Qingfeng Luo¹, Jie Li¹, Haiyan Xu², Wei Wang^{3

4}

Affiliations

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.
⁴ NMPA Key Laboratory for Respiratory and Anaesthetic Equipment, Shanghai, 201318.

PMID: 37288636
DOI: 10.3969/j.issn.1671-7104.2023.03.017

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.

Keywords: endoscopic injection needle; medical device registration and administration; technical evaluation.

Publication types

English Abstract

MeSH terms

Endoscopy*
Industry
Injections
Needles*
Risk Management