1.有与经营范围相适应的营业场所和仓库，并有特定的面积要求；
2.具有国家认可的专门从事产品经营的在职人员；
3、应有具有中专以上学历的与产品管理相关的技术人员；
4.具有与所经营的医疗器械相适应的质量管理体系。
许可证的所需材料
1.营业执照；
2.企业负责人、质量检验人员和技术人员的身份、学历和职称证明；
3.营业场所证明和地理位置图。
办理后的注意事项
1.医疗器械经营许可证的有效期只有5年。有效期需要延长的，医疗器械经营企业应当在有效期届满前6个月向原发证部门申请延期《医疗器械经营许可证》；
2.具有符合医疗器械经营质量管理要求的计算机信息管理系统，确保产品的可追溯性；
3.应建立销售记录制度和质量管理自查制度；
uses suitable for the business scope, and have specific arearequirements; 2. On-the-job personnel recognized by the state andspecialized in product management; 3. There should be technicalpersonnel related to product management with a technical secondaryschool education or above; 4. Have a quality management systemsuitable for the medical devices it operates. Materials requiredfor the permit 1. Business license; 2. The identity, educationalbackground and professional title certificate of the person incharge of the enterprise, the quality inspection personnel and thetechnical personnel; 3. Business site certificate and geographicallocation map. Matters needing attention after handling 1. Thevalidity period of the medical device business license is only 5years. If the period of validity needs to be extended, the medicaldevice trading enterprise shall apply to the original licenseissuing department for the extension of the Medical Device BusinessLicense 6 months before the expiration of the validity period; 2.Have a computer information management system that meets thebusiness quality management requirements of me
