顺义南彩北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富安全时效快可靠快捷

6.经营无菌和植入类产品的公司需建立计算机管理系统及计算机管理制度，能够保证产品从购进到销售整个过程的有效质量跟踪和追溯。

申请医疗器械经营许可证所需材料：

医疗器械经营许可证办理依据《北京市实施细则（2017年修订版）》，具体提交材料如下：

1．《 医疗器械经营许可申请表》（原件1份）

2．《营业执照》复印件（交验原件）；（复印件1份）

3．法定代表人、企业负责人、质量负责人的身份证明（查验原件）、学历或者职称证明复印件（对于统一采购渠道，采取连锁经营的非法人零售企业，提供连锁企业总部质量负责人身份证明、学历或者职称证明复印件）；（交验原件） （复印件共3份）

ompanies operating sterile and implanted products shall establish a computer management system and a computer management system to ensure the effective quality tracking and traceability of the whole process of products from purchase to sales. Materials required for applying for the Medical Device Business License: The medical device business license is handled according to the Implementation Rules of Beijing Municipality (2017 Revision), and the specific materials are as follows: 1. Application Form for Business License of Medical Device (1 original) 2. Copy of Business License (original copy for inspection); (1 copy) 3. The legal representative, head of the enterprise, quality, head of the identity certificate (check the original), certificate of education or title copy (for unified purchasing channels, take the chain enterprise