在北京办理三类医疗器械经营许可证有什么要求?企业要满足哪些条件?
办理流程是什么?
有与经营的第三类医疗器械相适应的营业场所和仓储场所,并提供经营场地的产权证明或者租赁合同;
有与经营的第三类医疗器械相适应的质量管理制度;
具有与经营的第三类医疗器械相适应的专业指导、技术培训和售后服务的能力,或者相关协议;
具有与经营的第三类医疗器械相适应的质量管理机构或者人员,质量管理人员应当具有国家认可的相关专业学历或者职称;
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;