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;
spection personnel and the technical personnel; 3. Business sitecertificate and geographical location map. Matters needingattention after handling 1. The validity period of the medicaldevice business license is only 5 years. If the period of validityneeds to be extended, the medical device trading enterprise shallapply to the original license-issuing department for the extensionof the Medical Device Business License 6 months before theexpiration of the validity period; 2. Have a computer informationmanagement system that meets the business quality managementrequirements of m