The Research on Reinspection Problems in Supervisory Sampling Inspection for Medical Devices
10.3969/j.issn.1671-7104.2017.04.012
- VernacularTitle:医疗器械监督抽验中复验问题的研究
- Author:
Hongyi YU
1
;
Xiaoyang QIAN
;
Jiahua HUANG
;
Yilan CHEN
;
Nan GU
;
Zhongcheng ZOU
Author Information
1. 国家食品药品监督管理局上海医疗器械质量监督检验中心
- Keywords:
medical devices;
supervisory inspection;
reinspection
- From:
Chinese Journal of Medical Instrumentation
2017;41(4):279-282
- CountryChina
- Language:Chinese
-
Abstract:
Supervisory sampling inspection is one of the administrative supervision measures for medical devices. As the reinspection work affects the final conclusion of sampling inspection, inappropriate overturn during the reinspection has already impaired the impartiality and authority of the supervisory inspection work. By the statistics of survey materials, this article analyzes the reasons for requesting reinspection and making overturns,and proposes a scheme for eliminating the interference factors such as the understanding divergences and the defects of standards,the inspection capacity and the issues of sampled devices, etc. To enhance the authoritative of reinspection, this article also proposes principals of evasion, precedence, arbitration and assessment, and the improvement of the reinspection workflow in order to make the reinspection work more appropriate, more efficient and more impartial.
