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AdvaMed对中美器械监管对话表示欢迎 - China Medical Device Manufacturer
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Wed, January 17th, 2018

2009年5月CMDM电子快讯 » 行业新闻
AdvaMed对中美器械监管对话表示欢迎

美国先进医疗技术协会(AdvaMed) 对美中商贸联合委员会 (JCCT)药品和医疗器械小组近日在华盛顿的商谈成果表示赞赏。

在此次商谈中,美国商务部和中国国家食品和药品管理局 (SFDA) 官员一致同意以国际标准为基础,制定一套独特的器械标识符和医疗器械命名法。双方还同意于今年6月在北京召开研讨会,就这些议题交换信息。

AdvaMed总裁兼首席执行官Stephen J. Ubl表示,“我们对上述会谈取得的成果表示热烈的欢迎,并期待在中国继续进行医疗器械监管结构现代化的进程中,与中国国家食品和药品管理局进一步展开合作。这些在行业内具有指导意义的交流合作,有助于增强两国间对上述重要议题的深入了解”。

此外,两国政府还同意尽可能展开信息交流,以加强监管协调,并商定于今年秋天在中国召开医疗设备工作组会议。下一次正式小组会议将于2010年4月在中国举行。美中商贸联合委员会为内阁级对话,每年举办一次,并设有各工业部门小组。其中药品和医疗设备小组每年召集一次会议,下面分设药品和医疗器械两个工作组,每年召集两次会议。

在会谈中,双方讨论了进一步完善中国器械管理程序的途径,下次的工作组会议上将会详细探讨。中国国家食品和药品管理局代表阐述了中国国内的不良事件报告制度,并保证在该制度实施过程中,与AdvaMed 成员公司积极合作。

会议结束后,应SFDA的要求,AdvaMed安排SFDA官员访问了强生、Covidien、波士顿科学国际有限公司和飞利浦医疗保健,向他们展示了美国医疗技术制造商生产的各种产品,以及制造商对产品质量和患者安全性的承诺。


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