Analysis and Improvement Suggestions on Change of Medical Devices Licensing Items.
10.3969/j.issn.1671-7104.2019.04.017
- Author:
Yongcheng REN
1
;
Chunxia YU
1
;
Huadong WANG
1
;
Yanjun XING
1
;
Wei AN
1
Author Information
1. Henan Provincial Food and Drug Evaluation Inspection Center, Zhengzhou, 450018.
- Publication Type:Journal Article
- Keywords:
change of licensing item;
countermeasure;
medical device;
technical evaluation
- MeSH:
Equipment and Supplies;
standards;
Government Regulation;
Licensure
- From:
Chinese Journal of Medical Instrumentation
2019;43(4):297-299
- CountryChina
- Language:Chinese
-
Abstract:
Based on the statistics of 350 technical evaluations of changes in licensing items of class Ⅱ passive and active medical devices completed in Henan province from July 2017 to November 2018, this paper summarized and analysed the common problems and requirements listed in the correction notifications of the technical evaluation, and put forward relevant countermeasures or suggestions, with a view to further speeding up the evaluation and approval of medical devices.
