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药监局:加强医疗器械监管 推进不良事件监测工作--亲稳网络舆情监测室
2013-02-21

  中新网2月20日电 据国家食品药品监督管理局网站消息,全国医疗器械监督管理工作电视电话会议19日在京召开。会议提出要完善监管法规文件、推进注册审评审批机制改革、加强标准和分类管理、强化生产经营监管加强检测机构管理、推进不良事件监测与再评价等具体工作安排。

February and, according to the state food and drug administration website news,The national medical equipment supervision and administration work video and telephone conference 19 held in Beijing.The meeting proposed to perfect the regulatory documents/Advance registration evaluation examination and approval mechanism reform/Strengthen standard and classification management/Strengthening production management regulation/Strengthening inspection institution management/Promote adverse event monitoring and evaluation to the specific work schedule.

  会议充分肯定了近年来医疗器械监管工作成效,分析了当前医疗器械监管面临的形势和任务,对2013年重点工作进行了部署,提出要完善监管法规文件、推进注册审评审批机制改革、加强标准和分类管理、强化生产经营监管、加强检测机构管理、推进不良事件监测与再评价等具体工作安排。

The meeting fully affirmed in recent years medical equipment supervision effectiveness,Analyzed the current situation of medical equipment supervision is facing the situation and tasks,In 2013, the key work deployment,Put forward to perfect the regulatory documents/Advance registration evaluation examination and approval mechanism reform/Strengthen standard and classification management/Strengthening production management regulation/Strengthening inspection institution management/Promote adverse event monitoring and evaluation to the specific work schedule.

  国家食品药品监督管理局副局长焦红要求,2013年医疗器械监管工作要以“保安全”为中心任务,全面实施“十二五”规划,着力改革和完善制度机制,努力形成“行政管理规范化,体系建设标准化,监管服务信息化,科研引领国际化”的监管格局,加强人才队伍和党风廉政建设,推动监管工作迈上新台阶。

State food and drug administration deputy bureau telephoto red requirements,2013 medical equipment supervision to work"secure"As central task,Full implementation of"1025"planning,To reform and perfect the system mechanism,Try hard to form"Administrative management standardization,Standardization system construction,Supervision service information,Leading international scientific research"Regulatory pattern,Strengthen the talent team and the style of the party construction of a clean and honest administration,Promote the supervision work to step on a new step.

  焦红指出,做好2013年医疗器械监管工作,必须统筹监管全局,落实监管责任。以制度建设为重点,完善监管法规体系;以改革创新为契机,进一步强化风险监管;以完善体系为目标,夯实监管基础;以提升技术能力为保障,为行政监管提供有力支撑;以信息化建设为手段,提升监管效能;以队伍建设为根本,不断提高监管水平。

JiaoGong pointed out that,Do 2013 medical equipment supervision work,Overall supervision must be global,Implement supervision responsibility.With the system construction as the key point,Perfect the regulatory system;To reform and innovation as an opportunity,To further enhance the risk supervision;To improve system as the goal,Tamp supervision basis;In order to enhance technical ability as the guarantee,Provide strong support for administrative supervision;By means of informatization construction,Improve supervision effectiveness;In team construction as the basis,Constantly improve the level of supervision.


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