长沙医疗器械经营许可证办理的条件有哪些？
一、办理条件
(一)具有与经营的医疗器械相适应的质量管理机构和人员;
(二)有与其经营的医疗器械相应的经营设施;
(三)有符合要求的储存条件,并具有保证所经营产品可追溯的设施设备;
(四)法律、法规规定的其他条件。
从事第三类医疗器械销售的企业,应当具备下列条件:
1、企业负责人及质量管理人员应具有相应专业学历和从业经验;
2、企业应具备独立承担民事责任的能力;
3、有与其销售的医疗器械相适应的经营场所,营业面积不少于200平方米;
4、配备专职或兼职的质量管理人员,负责质量管理工作;
5、建立并执行进货验收制度;
6、建立健全并执行不合格品的管理制度;
7、制定质量管理制度,包括质量策划、质量控制和质量改进等;
8、建立相关岗位培训计划,开展职工岗位技能培训,提高员工素质;
9、建立不良品的报告及处理制度和记录;
10、法律法规规定的其他内容。
长沙申办医疗资质公司,专注医疗行业,提供代办营业执照,食品流通许可证,卫生许可证,餐饮服务许可,劳务派遣,人力资源外包,建筑资质,设计资质,房地产开发证,物业管理证,道路运输许可证,烟草专卖局烟草零售许可,酒类零售许可,药品经营许可等一站式全托管服务。
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