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[Common Problems and Suggestions on Full Life-cycle Supervision and Administration of in Vitro Diagnostics]
Xiaohe Yang1, Linrong Ma2, Wen Wang1
1Zhejiang Center for Medical Device Evaluation(Zhejiang Provincial Center of Medical Device Adverse Events Monitoring and Safety Research), Hangzhou, 311121.
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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