Shenzhen Class II Medical Device License Application

销售医疗器械分为一类、Category II、Category three，销售一类的产品直接办理营业执照即可，销售二类医疗需要办理二类备案证，A physical business address is required，还要有医疗器械的软件以及医疗专业的质量管理人；销售三类需要看销售的产品来定办公室和库房的地址，要有质量管理人和主管检验师才可以，需要现场核查地址。

深圳市二类医疗器械许可证办理人员很简单，下面看看三类的人员情况：

1. 申请医疗器械经营许可证至少5个人，关外的公司至好6个人以上增加技术人员一名。
2. 经营范围含B类医疗器械的，企业负责人应具有医疗器械相关专业本科以上学历或医疗器械相关专业中级以上职称。
3. 经营范围含D类医疗器械的，应配备1名初级验光师以上职称的专业技术人员。
4. 企业负责人和质量负责人不得相互兼任。
5. 深圳《医疗器械经营企业许可证》、《医疗器械生产许可证》5）其它相关规定——关于深圳医疗器械生产许可证办理条件——满足条件的深圳医疗器械生产的单位可向相关部门提交相关材料，走医疗器械生产许可证

Process

，审核时间为30个工作日，审批通过的下发深圳医疗器械生产许可证，未通过的会以书面形式通告原因。

Our company specializes in registering medical device companies、Shenzhen Class II Medical Device License Application、Class II and III medical devices、Changes to medical devices、Additional items, etc.，Professional agency approval，Have extensive working experience in the industry。

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