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  Home Page >  hot news  > 注册医疗器械公司的条件

注册医疗器械公司的条件

  1、企业负责人应具有中专以上学历或初级以上职称。

  2、质检机构负责人应具有大专以上学历或中级以上职称。

  3、企业内初级以上职称工程技术人员应占有职工总数的相应比例。

  4、企业应具备相应的产品质量检验能力。

  5、应有与所生产产品及规模相配套的生产、仓储场地及环境。

  6、具有相应的生产设备。

  7、企业应收集并保存与企业生产、经营有关的法律、法规、规章及有关技术标准。

  8、生产无菌医疗器械的,应具有符合规定的生产场地。

 

经营医疗器械公司要办理的资质:医疗器械经营备案凭证、医疗器械经营许可证、医疗器械网络销售企业备案、互联网药品交易服务资格证书;

 

医疗器械公司注册流程

  1、注册医疗器械公司需要向当地食品药品管理局网站提交在线申请材料。

  2、当负责人的在线材料审查获得批准后,当地药品监管部门将预约查看经营场地。

  3、负责人提交书面申请材料,一旦获得批准,将颁发医疗器械企业许可证。

  4、负责人开设验资账户,股东出资,会计师事务有关验资报告。

  5、负责人申请营业执照。

  6、去雕刻公司所需印章,准备营业。

  7、转到相关部门处理组织代码证书。

  8、注册医疗器械公司的人员到相关部门申请税务登记证。


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