中新网8月6日电 据国家食品药品监督管理局网站消息，8月2～3日，全国医疗器械监督管理工作座谈会在山西太原召开。国家食品药品监督管理局党组成员、副局长边振甲强调，要以“铬超标药用胶囊”事件为警钟，汲取教训，不断规范监管行为，完善监管手段。

Beijing August 6, according to the state food and drug administration news web site，August 2 ~ 3,，The national medical equipment supervision and management symposium held in taiyuan shanxi。The state food and drug administration party members、The deputy director of the vibration armour emphasis，to“Chromium overweight medicinal capsule”Events for alarm bells，Learn your lesson，Constant supervision standard behavior，Perfect regulation means。

　　边振甲指出，2012年上半年，医疗器械监管各项工作取得明显成效，日常监管进一步深化。但是，当前医疗器械监管工作仍然存在复杂性和不确定性，须不断完善医疗器械相关配套规章和规范性文件，明确权责关系。持续创新审评审批机制，提高审查质量和效率，加强标准、编码、分类等工作，夯实监管基础，不断细化日常监管程序，强化执法威慑力。加强不良事件监测，及时反馈问题，加快检验检测机构建设步伐，提升技术支撑能力。

Edge vibration armour points out that，In the first half of 2012，The medical equipment supervision has achieved remarkable success，The daily supervision further deepen。but，The current medical equipment supervision work remains complexity and uncertainty，Must constantly improve the medical equipment related regulations and normative documents，Clear accountability relationship。Continuous innovation evaluation mechanism for examination and approval，Improve the quality and efficiency of examination，Strengthen standard、coding、Classification work，Laying the foundation supervision，Continuously detailed daily supervision program，Strengthen law enforcement deterrence。Strengthen the monitoring of adverse events，Timely feedback problems，To speed up the examination organization construction pace，Enhance the technical support ability。

　　边振甲强调，要以“铬超标药用胶囊”事件为警钟，汲取教训，举一反三，充分查找医疗器械监管各个环节在风险意识、监管机制、执行力度和技术支撑等方面的不足，进一步强化责任感和使命感，以监管为民为指导思想，持续改进监管作风，不断规范监管行为，完善监管手段。

Edge vibration armour emphasize，to“Chromium overweight medicinal capsule”Events for alarm bells，Learn your lesson，extrapolate，Fully find medical equipment supervision each link in risk awareness、Supervision mechanism、Enforcement and technical support, and other aspects of the insufficiency，To further enhance the sense of responsibility and the sense of mission，To regulate as the guideline for the people，Continuously improve supervision style，Constant supervision standard behavior，Perfect regulation means。

　　边振甲称，要进一步落实地方政府负总责、监管部门各负其责、企业是第一责任人的要求，高度警惕系统性风险，坚决打击行业潜规则。要继续加强能力建设和队伍建设，以《国家药品安全“十二五”规划》为目标，全面落实医疗器械监管各项工作任务。

Edge vibration armour says，We will further implement local government overall responsibility、Each its supervision department、Enterprise is the first person in requirements，Highly vigilant systemic risk，Strike resolutely industry unspoken rules。To continue to strengthen the ability construction and team construction，to《The national drug safety“1025”planning》As the goal，To carry out the medical equipment supervision all tasks。