[Risk Management Analysis of Medical Device Registration Self-inspection]

Yonghong Li; Jianning Zhu; Yanxue Fang; Hua Yang

doi:10.3969/j.issn.1671-7104.2023.05.015

[Risk Management Analysis of Medical Device Registration Self-inspection]

Zhongguo Yi Liao Qi Xie Za Zhi. 2023 Sep 30;47(5):545-549. doi: 10.3969/j.issn.1671-7104.2023.05.015.

[Article in Chinese]

Authors

Yonghong Li¹, Jianning Zhu¹, Yanxue Fang¹, Hua Yang¹

Affiliation

¹ Center for Inspection of Gansu Medical Products Administration, Lanzhou, 730070.

PMID: 37753895
DOI: 10.3969/j.issn.1671-7104.2023.05.015

Abstract

Through the analysis of laws and policies related to registration self-inspection, visiting and researching enterprises, holding symposiums, and issuing nationwide questionnaires, the risks in the registration self-inspection process were summarized, analyzed, and evaluated. From the aspects of regulatory departments and manufacturing enterprises, we suggest to improve China's medical device registration regulations system and reduce the risks of all parties in the registration self-inspection work.

Keywords: medical device; registration self-inspection; risk management.

Publication types

English Abstract

MeSH terms

Commerce*
Medical Device Legislation
Risk Management*