质量体系对医疗器械标签、说明书和包装的要求探究

To Explore the Quality System for Medical Equipment Labels and Packaging Requirements

本文概括性地介绍了中国、美国医疗器械质量体系法规和ISO13485:2003标准对医疗器械标签、说明书和包装的控制要求,从质量体系的角度分析了对医疗器械标签、标识和包装的控制,从形式和内容方面比较了这些要求的异同,便于医疗器械制造商在实施质量体系时进行全面的考量。

Briefly introduce the Quality system control requirement to label and packaging of Medical Device quality system regulation from SFDA, U.S.FDA, and ISO13485：2003 international standard, And simply compare and analyse the sameness and differentia among these quality system regulation and standard. To facilitate medical device Manufacturer comprehensively consider these requirement when planning and implementation of Medical device quality system.