北京申请办理二类医疗器械许可证的条件:
1、要有与医疗器械相关的技术人员和管理人员,质量管理人员一定要具备国家认同的专业文凭和职位。
(医疗器械的储存、销售和管理没有医学相关技术人员很容易出现问题,因此监督机构要求大家有专业人员从产品的进货、储存、销售和售后流程中对企业承担,从而进一步减少企业的经营风险。)国家不允许个人销售或个体户销售医疗器械,以企业为主体销售和经营医疗器械。
2、具备与经营规模和经营范围相适应的相对独立的经营场所和相对应的储藏条件,包含符合医疗器械产品特性要求的储藏设施、设备(需要经营场所,管理员工和销售的产品,减少产品风险问题,与此同时为用户提供信任)。
3、不断完善的产品质量管理体系,包含采购、进货验收、仓储物流存放、出入库审核、质量跟踪和不良事件报告体系。二、经营许可证是营业执照吗二者不能等同。
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