Port communication深圳二类医疗器械经营备案是法律依据医疗器械监督管理条例第三十条，相关条件从事医疗器械经营活动，应当有与经营规模和经营范围相适应的经营场所和贮存条件，以及与经营的医疗器械相适应的质量管理制度和质量管理机构或者人员。
二类医疗器械经营备案申请材料
Require
：
- 第二类医疗器械经营备案表
- 营业执照和组织机构代码证复印件
- legal representative、Business person in charge、Proof of identity of the quality manager、学历或者职称证明复印件
- 组织机构与部门设置说明
- Business scope、Description of business methods;
- Business premises、Geographical location map of warehouse address、floor plan、Property ownership certificate or a copy of the lease certificate issued by the house leasing agency;
- Business facilities、Device catalog;
- Operation quality management system、Work program and other file directories;
- Certificate of authorization of the person in charge。
Process
图
- 现场递交材料;
- 确认受理(conform to
Require
的受理，Does not meet
Require
的退回);
- Approval;
- 办结打证有需要的直接联系林经理快当天能办好相关产品：深圳二类医疗器械经营备案凭证办理的详细流程及资料
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