Research on Classifed Punishments on Manufacturers of Unconformity Products in Supervision and Sampling Inspection of Medical Devices.
10.3969/j.issn.1671-7104.2018.06.014
- Author:
Pei LI
1
;
Xin LI
2
;
Xiaolong QIANG
1
;
Fenglian MA
1
;
Zhiqiang WU
1
Author Information
1. Guangxi Testing Center for Medical Devices, Nanning, 530021.
2. Yangzhou Food and Drug Administration, Yangzhou, 225002.
- Publication Type:Journal Article
- Keywords:
classified punishments;
severity classification of unconformity;
supervision and sampling inspection of medical devices
- MeSH:
Equipment Failure;
Equipment and Supplies;
standards;
Punishment
- From:Chinese Journal of Medical Instrumentation
2018;42(6):440-443
- CountryChina
- Language:Chinese
-
Abstract:
Theories of classified management which are based on risk governance are introduced into the newly revised , but the punishments on the manufacturers of unconformity products are not classified based on the severity and risks caused by the test items. This article analysed the disadvantages of current punishment measures on the manufacturers of unconformity products and the theoretical basis of classified punishments. The feasibility of classified punishments had also been studied and some basis of discretionary punishments was provided under the current regulations.
