总局办公厅关于做好医疗器械检验有关工作的通知（食药监办械管〔2017〕187号）！(www.hlongmed.com)

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Date()/36e5)];总局办公厅关于做好医疗器械检验有关工作的通知食药监办械管〔2017〕187号2018年01月03日 发布各省、自治区、直辖市食品药品监督管理局：　　为贯彻落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》（厅字〔2017〕42号）和《国务院关于改革药品医疗器械审评审批制度的意见》（国发〔2015〕44号），切实发挥好医疗器械检验机构技术支撑力量，保证医疗器械注册工作秩序，现就有关要求通知如下：　　一、各省、自治区、直辖市食品药品监督管理局要高度重视医疗器械检验工作，充分认识医疗器械检验在医疗器械注册工作中的重要支撑作用，从全国医疗器械注册管理工作大局出发，进一步增强责任感和使命感，积极落实《财政部、国家发展改革委关于清理规范一批行政事业性收费有关政策的通知》（财税〔2017〕20号）和《食品药品监管总局办公厅关于停征部分行政事业性收费后做好经费保障确保工作正常开展的通知》（食药监办财函〔2017〕199号）的要求，争取各级财政对所属医疗器械检验机构支持，妥善做好检验工作经费保障，调动所属医疗器械检验机构主动性和积极性，在医疗器械检验环节做好技术服务工作，确保检验相关工作有序开展，为深化审评审批制度改革鼓励医疗器械研发创新贡献力量。　　二、各省、自治区、直辖市食品药品监督管理局要进一步加强对所属医疗器械检验机构的监督管理，做好指导协调，畅通医疗器械检验工作投诉渠道，认真倾听申请企业相关诉求，了解实际困难，主动协调相关工作，妥善处理检验过程中的相关问题，监督医疗器械检验机构按照检验工作相关规定开展检验，包括受理跨省检验申请、合同中明确规定具体检验时限、在合理工作时限内完成检验并出具检验报告等，对于存在问题的，要加强协调督办和通报，并及时予以纠正。　　三、各医疗器械检验机构要按照《医疗器械监督管理条例》（国务院令第680号）和《医疗器械注册管理办法》（食品药品监管总局令第4号）、《体外诊断试剂注册管理办法》（食品药品监管总局令第5号）等规定，对医疗器械注册申请人委托检验的注册产品依据产品技术要求进行检验，并出具检验报告用于产品注册。各医疗器械检验机构要严格按照《食品药品监管总局关于印发医疗器械检验机构开展医疗器械产品技术要求预评价工作规定的通知》（食药监械管〔2014〕192号）的要求开展产品技术要求预评价工作，充分考虑国家标准、行业标准的完整性和适宜性，确保检验报告符合产品注册的相关要求。食品药品监管总局办公厅2017年12月29日返回评论(0)$(document).ready(function 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