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。
注:因版权方要求,不能公开全文,如需全文,请咨询杂志社
热门期刊服务
Journal of Hydrodynamics Journal of Huazhong University of Science and Technology The Journal of China Universities of Posts and Telecommunications Journal of Genetics and Genomics Journal of Iron and Steel Research Journal of Systems Science and Complexity World Journal of Gastroenterology Journal of Computer Science and Technology International Journal of Minerals Metallurgy and Materials Applied Mathematics:A Journal of Chinese Universities International Journal of Mining Science and Technology Journal of Systems Science and Systems Engineering