Our corporate culture:

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In the company, in each position has a top talents, crafts authentic baristas are always at your side to a cup of freshly brewed coffee, fragrant and professional fitness instructor in you after work you can be your personal trainer. You can enjoy it as much as you can, or you can sweat in a spacious gym. After work, I can still enjoy the excellent quality of life.

Our corporate culture:

-

In the company, in each position has a top talents, crafts authentic baristas are always at your side to a cup of freshly brewed coffee, fragrant and professional fitness instructor in you after work you can be your personal trainer. You can enjoy it as much as you can, or you can sweat in a spacious gym. After work, I can still enjoy the excellent quality of life.

新闻中心COMPANY NEW

四川省局加大医疗器械临床试验监督检查力度

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2018-2-27 10:56:10

为落实监管从严要求,确保医疗器械申报资料数据真实,四川省局在去年探索性开展医疗器械临床试验现场核查的基础上,今年上半年严格按照《医疗器械临床试验质量管理规范》要求,组织开展了2017年第一批医疗器械临床试验监督抽查工作,具体由四川省食品药品审查评价及安全监测中心实施。

从3月下旬开始,四川省局先后抽调临床专家、检查员组成6个检查组,对5家医疗器械生产企业的12个医疗器械产品临床试验数据真实性、合规性开展监督检查,共涉及10家临床机构。

总体来讲,四川省医疗器械临床试验相对规范、风险可控。抽查中发现,主要存在实际操作偏离临床试验方案、原始数据记录不完整等问题。通过检查,以点带面,进一步规范了四川省医疗器械临床试验活动,加强了与临床专家的沟通交流,增强了四川省医疗器械审评审批人员的认识,有利于提升四川省整体审评审批能力。

下一步四川局将继续加强监管,推动医疗器械审评审批制度改革,助推四川省医疗器械产业健康持续发展。