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)
ent system to ensure the effective tracking andtraceability of the whole process of products from purchase tosales. Materials required for applying for the Medical DeviceBusiness License: The medical device business license is handledaccording to the Implementation Rules of Beijing Municipality (2017Revision), and the specific materials are as follows: 1.Application Form for Business License of Medical Device (1original) 2. Copy of Business License (original copy forinspection); (1 copy) 3. The legal representative, head of theenterprise, of the identity certificate (checkthe