中新网9月13日电 据国家食药监局网站消息，日前，国家食药监局发布《关于加强高电位治疗设备监督管理的通知》。通知强调，要加强医疗器械监督管理，保证公众用械安全。

Beijing on September 13, according to the national food, the administration's web site message,a,National food, the administration's release[On strengthening the high potential treatment equipment supervision and management of the notice].Notice emphasize,To strengthen the supervision and administration of medical devices,Ensure public security with machinery.

　　针对国家医疗器械质量公告反映的高电位治疗设备不合格率高、强制性行业标准执行不到位的问题，通知就加强该类产品监督管理做出如下部署：

According to the medical equipment quality announcement reflect high potential treatment equipment fraction defective high/Mandatory industry standard execution does not reach the designated position problem,Notice on strengthening the supervision and administration of this kind of products are made as follows deployment:

　　一、医疗器械生产企业作为保证医疗器械质量的第一责任人，必须认真学习有关强制性行业标准，了解标准要求，在产品研发、生产、经营中全面贯彻强制性行业标准及相关法规要求，确保产品质量。

a/Medical device manufacturing enterprise as a guarantee medical instrument quality the first responsible institution,We must earnestly study relevant mandatory industry standard,Understand the standard requirements,In the product research and development/production/Operation of the comprehensive implementation of the mandatory industry standard and related regulations,To ensure that the quality of products.

　　二、各省(区、市)食品药品监督管理局要加强对辖区内高电位治疗设备生产企业的日常监管，监督企业根据《关于印发进一步加强和规范医疗器械注册管理暂行规定的通知》要求组织生产。

two/provinces(area/city)The food and drug supervision and administration within its jurisdiction to strengthen the high potential treatment equipment production enterprise's daily supervision,Supervision enterprise according to[About print and distribute to further strengthen and standardize medical device registration management interim provisions of the notice]Organize production requirements.

　　三、各省(区、市)食品药品监督管理局要严格依照《高电位治疗设备》行业标准要求，特别是依照标准中高电位治疗设备定义，明晰产品类别，做好相关产品重新注册等工作。

three/provinces(area/city)Food and drug administration in accordance with to strictly[High potential treatment equipment]Industry standards,Especially in accordance with the standard of high potential treatment equipment definition,Clear product category,Make related products to register, etc.

　　四、国家局医疗器械标准管理中心和有关标准化分技术委员会要做好《高电位治疗设备》行业标准的宣贯工作，为企业及时掌握标准信息，正确了解标准内容和要求提供技术支持。

four/GuoGuJu medical equipment standard management center and the relevant standard HuaFen technical committee to do[High potential treatment equipment]Industry standard work stable cross,For the enterprise to grasp standard information,Correctly understand standard contents and requirements to provide technical support.

　　五、各相关医疗器械检测机构要加强高电位治疗设备检测工作，在注册检测中严格执行《高电位治疗设备》行业标准要求。

five/The relevant medical device testing institutions should strengthen the high potential treatment equipment testing work,The registered testing strictly carry out[High potential treatment equipment]Industry standards.