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美国工业协会对中国简化监管流程表示欢迎 - China Medical Device Manufacturer
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Sat, January 20th, 2018

2009年11月CMDM电子快讯 » 行业新闻
美国工业协会对中国简化监管流程表示欢迎

美国医疗技术工业协会AdvaMed(www.advamed.org) 对中国主管部门就简化医疗器械监管流程所做的一系列承诺表示欢迎。中国在2009年10月28–29日于杭州召开的美中商贸联合委员会(JCCT)会议中宣布了上述措施。

承诺内容如下:

为消除产品召回过程中的繁琐程序,中国宣布卫生部和食品药品监督管理局将保留产品召回的相关职责。

• 中国不再要求公司按照中国注册条件在产品出口国进行产品注册。

• 某些类别的仪器将无需在中国进行临床试验。而是采用一种基于风险的评估方法,而且在中国以外地区进行的临床试验的结果将被纳入考虑范围。

• 如果医疗器械制造商证明其产品符合国际标准并能提供合理的科学证据,中国将考虑免除审批前其产品样品在中国实验室的检测。

• 中国政府保证力争实施与全球医疗器材协合会和亚洲医疗器械法规调和工作组版布的医疗器械指导文件相一致的法规、规章和通知。

AdvaMed全球战略分析执行副总裁Ralph Ives说:“AdvaMed对中国做出的承诺表示欢迎,我们相信这必将简化医疗器械监管流程,并使中国人民能及时享用到最具创新性的先进医疗技术产品。”

“AdvaMed在美国政府的支持下,近年来一直致力于消除中国监管流程中的繁琐环节,”Ives补充道。“我们对JCCT联合主席美国贸易代表Ron Kirk、美国商务部长Gary Locke和中国国家副总理王岐山的领导工作深表感谢,同时对双方工作人员的辛勤工作表示感谢。”


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