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；

eriod of validity needs to be extended, the medical device trading enterprise shall apply to the original license-issuing department for the extension of the Medical Device Business License 6 months before the expiration of the validity period; 2. Have a computer information management system that meets the business quality management requirements of medical devices to ensure the traceability of products; 3. A sales record system and a quality management self-inspection system should be established;