Common Problems and Suggestions on Full Life-cycle Supervision and Administration of Diagnostics / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 129-132, 2018.
Article
in Chinese
| WPRIM
| ID: wpr-774491
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Product Surveillance, Postmarketing
/
Diagnosis
/
Equipment and Supplies
Type of study:
Diagnostic study
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2018
Type:
Article
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