FDA自愿提交ISO13485：2003质量体系审核报告程序的思考

摘要

本文概括性地介绍了美国F D A的《医疗器械I S O13485：2003自愿性审核报告提交程序》。结合FDA及其他国家和地区的监管部门对医疗器械制造商质量体系的检查，介绍了该程序的主要原则、适用情况；同时探讨了引入社会资源对医疗器械进行监管的科学、合理性，为我国医疗器械监管者在建立和修订我国的医疗器械法规时提供借鉴。%Brielfy introduce FDA Medical device ISO13485:2003 Voluntary audit report submission pilot program, combination with the quality system inspection of FDA and other regulatory affair, outlined the principle and application of this pilot program. And discuss that scientiifcity and rationality of introduce society resource to medical device supervision. Provide reference to our medical device supervisor when establish or revise China medical device regulation.