Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation.
10.3969/j.issn.1671-7104.2023.06.017
- Author:
Yanxue FANG
1
;
Xinyan ZHANG
2
;
Yonghong LI
1
;
Hua YANG
1
Author Information
1. Center for Inspection of Gansu Medical Products Administration, Lanzhou, 730070.
2. Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA, Shanghai, 201210.
- Publication Type:Journal Article
- Keywords:
improvement;
medical device;
registration self-test;
technical evaluation
- MeSH:
Medical Device Legislation
- From:Chinese Journal of Medical Instrumentation
2023;47(6):680-683
- CountryChina
- Language:Chinese
-
Abstract:
Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.
