Analysis of Changing the Original Test Result after Retesting in National Medical Device Sampling and Testing from 2013 to 2016.

Author: Qing HAO ¹ ; Xintao ZHANG ¹ ; Xiao LI ¹ ; Jiong ZHU ¹ ; Qingsheng ZHANG ¹ ; Xian SHI ¹
Author Information

1. National Institutes for Food and Drug Control, Beijing, 102629.
Publication Type:Journal Article
Keywords: changing the original test result; medical device; retesting; sampling and testing
MeSH: Equipment and Supplies; standards; Quality Control
From: Chinese Journal of Medical Instrumentation 2018;42(1):56-57
CountryChina
Language:Chinese
Abstract: The types and the reasons of changing the original test result after retesting in national medical device sampling and testing from 2013 to 2016, are summarized and analyzed. Firstly, collecting data of "standards not complied" and retesting. Then, giving specific examples when summarizing five types of changing the original test result after retesting. Meanwhile, analyzing the relevant reasons, discovering the deep problems. Finally, giving suggestions for the above problems.