Common Problems and Suggestions on Full Life-cycle Supervision and Administration of Diagnostics.
10.3969/j.issn.1671-7104.2018.02.014
- Author:
Xiaohe YANG
1
;
Linrong MA
2
;
Wen WANG
1
;
Hui ZHEN
1
Author Information
1. Zhejiang Center for Medical Device Evaluation(Zhejiang Provincial Center of Medical Device Adverse Events Monitoring and Safety Research), Hangzhou, 311121.
2. Zhejiang Center for Drug Certification & Inspection, Hangzhou, 310013.
- Publication Type:Journal Article
- Keywords:
common problems;
full life-cycle supervision;
in vitro diagnostics;
revisions on regulations
- MeSH:
Diagnosis;
Equipment and Supplies;
Product Surveillance, Postmarketing
- From:
Chinese Journal of Medical Instrumentation
2018;42(2):129-132
- CountryChina
- Language:Chinese
-
Abstract:
This article analyzes common problems and offers some suggestions on full life-cycle supervision and administration process of diagnostics, including premarket technical evaluations, pre-market QMS on-site inspections, postmarket adverse event surveillance, unannounced inspections and re-evaluation, from regulators' perspectives. It aims to provide technical reference for revisions on regulations, and help government administrators to figure out major points in daily regulatory practice.
