文档介绍：
中美两国医疗器械注册对比研究
刘清峰*
(上海医疗器械高等专科学校管理系,上海市
200093)
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摘要:为改进和完善中国医疗器械注册制度,采用对比分析法研究了中美两国政府对医疗器
械注册管理制度的差异,结果表明中美两国在医疗器械产品注册的法律基础、注册审批体制、
器械命名与医学分类、监督管理分类、产品注册方式及注册指导思想方面存在着差异,同时,
中国实行着独特的医疗器械注册产业准入与重新注册制,美国在 510(k)申请时有第三方
审核制。建议我国提升医疗器械监督管理的法律地位,补充法律法规的缺失项目,改变我国
医疗器械产品注册分级制,建立起集中审评审批制,建立全国统一医疗器械命名和编码制度,
为医疗器械监督管理构建起基础性平台,建立起常态化的医疗器械监管分类机构,研究实施
新的科学的监管分类标准,更新审评理念,创新审批手段,取消医疗器械注册的产业准入与
重新注册制。
关键词:卫生事业管理;中国和美国;医疗器械注册;对比
中图分类号:R19
Comparison of Medical Device Registration Between China
and the United States
Liu Qingfeng
(Shanghai Medical Instrumentation College Management Department,200093,China)
Abstract:
In order to improve and perfect Chinese medical device registration system, this paper
researched the differences on the medical device registration management system between the two
governments of China and America parative analysis. The results indicated differences
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between the two countries were there in the following facets: legal basis for cooperation in the
medical device product registration, registration and approval system, device naming and medical
classification, regulation and management of the classification, guiding ideology of product
registration. China has been implemented a unique medical device industrial access system and
re-registration system while there is a third party 510 (k) application audit system in the .. It
suggested that improving the legal status of the medical device regulation, supplementing the
missing item of laws and regulations, changing the medical device product registration
classification system and establishing a centralized review and approval system, establishing the
unified national medical device naming and coding system for the regulation of medical devices,
building up the basic platform for regulation, establishing normal classification of medical device
regulatory agencies, studying and implementing the scientific classification criteria for new