1.
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.