Status Analysis and Improvement Suggestions on the Renew Registration of Passive Medical Devices.
10.3969/j.issn.1671-7104.2018.05.018
- Author:
Dandan HOU
1
;
Yungao CHU
1
;
Zhizhen ZHONG
1
Author Information
1. Center for Certification & Evaluation of SHFDA, Shanghai, 200020.
- Publication Type:Journal Article
- Keywords:
correction;
passive medical device;
renew registration;
technical evaluation
- From:Chinese Journal of Medical Instrumentation
2018;42(5):375-377
- CountryChina
- Language:Chinese
-
Abstract:
The article collected 250 renew registration of domestic Class Ⅱ passive medical devices from Jan. 2016 to Aug. 2017 in Shanghai. It summarized the common problems listed in the correction notifications of the technical evaluation, and then provides some relevant countermeasures or suggestions. So that we can further speed up the evaluation and approval of medical devices.
