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医疗器械公司资质办理流程要求

港信通国际商务咨询有限公司从事专业公司注册企业代理以及相关的咨询业务的企业公司自成立以来一直坚持诚信为本的原则贯彻以人为本的基本思想本着积极热心尽力负责的态度给每一家客户精心服务细心策划

凭借公司员工的专业素质和对业内信息的全方位把握让我们与行业众多伙伴建立了密切的协作关系的同时也赢得了极佳的口碑医疗器械公司资质

Process

Require

条件1.具有与经营规模和经营范围相适应的质量管理机构或者专职质量管理人员

质量管理人员应当具有国家认可的相关专业学历或者职称

  1. 具有与经营规模和经营范围相适应的相对独立的经营场所
  2. 具有与经营规模和经营范围相适应的储存条件包括具有符合医疗器械产品特性

Require

的储存设施设备

  1. 应当建立健全产品质量管理制度包括采购进货验收仓储保管出库复核质量跟踪制度和不良事件的报告制度等
  2. 应当具备与其经营的医疗器械产品相适应的技术培训和售后服务的能力或者约定由第三方提供技术支持

医疗器械公司资质

Process

Require

由于全球医学水平的不断发展全球老年人口逐渐增多等原因,2012-2025年全球医疗器械市场规模呈波动上升趋势。2025Year,全球医疗器械市场规模为4030亿美元较上年增长4.13%预计2025年全球医疗器械市场将继续维持上升趋势市场规模超过4200亿美元

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