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;
the medical devices it operates. Materials required for thepermit 1. Business license; 2. The identity, educational backgroundand professional title certificate of the person in charge of theenterprise, the quality inspection personnel and the technicalpersonnel; 3. Business site certificate and geographical locationmap. Matters needing attention after handling 1. The validityperiod of the medical device business license is only 5 years. Ifthe period of validity needs to be extended, the medical devicetrading enterprise shall apply to the original license-issuingdepartment for the extension of the Medical Device Business License6 months befor