[Discussion on the Authenticity Verification Method in the Verification of Medical Device Registration Quality Management System]

Fenglin Liu; Hongzhong Chen; Qian Chai; Shenglin Yang; Xiaochen Wang; Shanshan Liu; Yunjuan Zhang; Dandan Dong

doi:10.3969/j.issn.1671-7104.2023.03.015

[Discussion on the Authenticity Verification Method in the Verification of Medical Device Registration Quality Management System]

Zhongguo Yi Liao Qi Xie Za Zhi. 2023 May 30;47(3):309-311. doi: 10.3969/j.issn.1671-7104.2023.03.015.

[Article in Chinese]

Authors

Fenglin Liu¹, Hongzhong Chen¹, Qian Chai¹, Shenglin Yang¹, Xiaochen Wang¹, Shanshan Liu¹, Yunjuan Zhang¹, Dandan Dong¹

Affiliation

¹ Shandong Center for Food and Drug Evaluation and Inspection, Jinan, 250000.

PMID: 37288634
DOI: 10.3969/j.issn.1671-7104.2023.03.015

Abstract

Authenticity verification is a very important aspect of medical device registration quality management system verification of medical device. How to verify the authenticity of samples is a problem worth discussing. This study analyzes the methods of authenticity verification from the aspects of product retention sample, registration inspection report, traceability of records, hardware facilities and equipment. In order to provide reference for relevant supervisors and inspectors in the verification of registration quality management system.

Keywords: authenticity verification; medical device; registration quality management system verification.

Publication types

English Abstract