北京申请办理二类医疗器械许可证的条件:
1、要有与医疗器械相关的技术人员和管理人员,质量管理人员一定要具备国家认同的专业文凭和职位。
(医疗器械的储存、销售和管理没有医学相关技术人员很容易出现问题,监督机构要求大家有专业人员从产品的进货、储存、销售和售后流程中对企业承担,从而减少企业的经营风险。)国家不允许个人销售或个体户销售医疗器械,以企业为主体销售和经营医疗器械。
2、具备与经营规模和经营范围相适应的相对独立的经营场所和相对应的储藏条件,包含符合医疗器械产品特性要求的储藏设施、设备(需要经营场所,管理员工和销售的产品,减少产品风险问题,为用户提供信任)。
How long does it take to approve theregistration of the class III medical device license? (1)Acceptance: The applicant shall apply to the AdministrativeAcceptance Service Center, submit the application materials inaccordance with the catalogue listed in Article 6 of theInstructions, and the staff of the Acceptance Center shall examinethe application materials in accordance with the requirements ofthe Acceptance Standards for the Registration and ApplicationMaterials of Domestic Third Class and Overseas Medical Devices(National Drug Administration [2005] No.111). Where the applicationitem does not need to obtain an administrative license according tolaw, The applicant shall be informed immediately of thenon-acceptance of the application; Where the application items donot fall within the scope of the functions and powers of theadministrative organ according to law, A decision shall be madeimmediately, And inform the applicant to apply to the relevantadministrative organ;