Abstract
This article analyzes common problems and offers some suggestions on full life-cycle supervision and administration process of in vitro 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.
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More From: Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation
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