CFDA Announces Quality Standards For In Vitro Diagnostic Reagents
This article was originally published in PharmAsia News
Executive Summary
China FDA released quality standards for vitro diagnostic reagents, covering staffing, quality management, and facility requirements.
China FDA released quality standards for vitro diagnostic reagents, covering staffing, quality management, and facility requirements. Employees responsible for managing should be college-educated and possess relevant product and legal knowledge, and the chief QA officer should have relevant college education and three years of experience. The standards also span production, storage, low-temperature storage environments, logistics, information systems and facility maintenance. (Click Here For More - Chinese Language
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"CFDA: In Vitro Reagent (Med Device) Quality Standards For Product Acceptance" - news.pharmnet.com.cn (5/23/2013)