科学研究我国医疗器械行业的“十三五”发展趋势,认真做好医疗器械监管“十三五”规划编制工作,医疗器械标准管理中心(以下简称标管中心)于2015年2月9至10日在上海组织召开了“医疗器械标准化建设“十三五”前期规划工作研讨会”。参加研讨的有北京市食品药品监督管理局、上海市医疗器械检测所、天津市医疗器械检验所和医疗器械行业协会共10余人参加会议。
标管中心王云鹤副主任到会并讲话。他指出,医疗器械产品的安全问题是重大基本民生问题,而医疗器械的标准体系是我国医疗器械行业健康发展的重要基础保障,在“十一五”和“十二五”期间已经得到了国家的高度重视,给予了经费支持。做好“十三五”规划是国家食品药品监督管理总局组建后的第一个5年规划,是我国医疗器械监管事业创新发展的重要战略机遇期,务必要准确把握当前形势,汲取前两个五年规划的经验,制定出科学合理的医疗器械标准化“十三五”发展规划,全面提升监管能力和水平,切实保障人民群众用械安全。
各承担单位分别在前期调研的基础上,做了医疗器械标准化建设“十三五”规划整体思路、医疗器械标准现状、监管需求和行业发展形势等专题汇报,与会专家对“十三五”规划中的关键问题开展了深入讨论,并进一步提出了完善意见。
医疗器械标准管理研究所负责人根据会议研讨情况,对“十三五”规划的研究进展做了阶段小结,部署了下一步工作要求,这为编制我国医疗器械标准化建设“十三五”规划起到了重要的推动作用。
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