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
s sites and warehouses suitable for the business scope, andhaving specific area requirements; 2. On-the-job personnelrecognized by the state and specialized in product management; 3.There should be technical personnel related to product managementwith a technical secondary school education or above; 4. Have aquality management system suitable for the medical devices itoperates. Materials required for the permit 1. Business license; 2.The identity, educational background and professional titlecertificate of the person in charge of the enterprise, the qualityinspection personnel and the technical personnel; 3. Business sitecertificate and geographical location map. Mattersneeding
