北京丰台》医疗器械网络销售备案》办理周期1个月》专业辅助办理

申请医疗器械三类证的审批流程主要包括以下环节：

申请前准备

• 确认资质条件：企业需确保自身满足相应的人员、场地、设施设备等要求。例如，质量负责人应具备医疗器械相关大专以上学历或者中级以上技术职称，且有 3 年以上医疗器械经营质量管理工作经历；经营场所和仓库需达到规定的面积标准，并符合相应的环境要求16。

• 准备申请材料：通常包括企业营业执照副本复印件、法定代表人及相关人员的身份证明和学历职称证明复印件、经营场所与库房的证明文件、医疗器械经营许可申请表、企业产品质量管理制度文件等 146。

提交申请

• 网上申报：一般需登录当地的政务服务网或食品药品监督管理部门指定的在线平台，如北京市丰台区的企业可登录北京市政务服务网，进入 “第三类医疗器械经营许可” 事项的网上办理页面，按要求填写申请表并上传申请材料34。

• 现场提交纸质材料：在网上预审通过后，按照要求将纸质材料提交至指定的审批窗口3。

受理与审查

• 受理：审批部门收到申请材料后，会对其进行初步审核，检查材料是否齐全、是否符合法定形式等。若材料符合要求，将予以受理，并发出受理通知书36。

• 技术审查：组织人员对申请材料进行详细审查，评估企业的质量管理体系、人员资质、场地设施等是否满足医疗器械三类经营的要求，必要时会进行现场检查67。

• 现场核查：核查人员会实地查看企业的经营场所、仓库，检查设施设备是否完备、人员是否符合资质要求、质量管理体系是否有效运行等。例如，查看仓库的布局是否合理、储存条件是否符合医疗器械的要求，核实质量负责人等关键岗位人员的能力和工作经验等357。

审批决策

• 综合评审：根据技术审查和现场核查的结果，审批部门进行综合评估，形成审批意见6。

• 作出决定：对符合要求的申请，作出准予许可的决定，并颁发医疗器械三类经营许可证；对不符合要求的申请，作出不予许可的决定，并书面说明理由6。

后续管理

• 证书管理：企业应妥善保管医疗器械三类经营许可证，在许可的经营范围内开展业务，并按照规定在产品包装或经营场所显著位置展示许可证。

• 监督检查：监管部门会定期对持证企业进行监督检查，确保企业持续符合法规要求，如检查企业的经营活动是否合规、质量管理体系是否有效维持等6 。

• Acceptance: After receiving the application materials, the approval department will conduct a preliminary review to check whether the materials are complete and comply with the legal form. If the materials meet the requirements, they will be accepted and a notice of acceptance will be issued.

• Technical review: Organize personnel to conduct a detailed review of the application materials, evaluate whether the company's quality management system,ualifications, site facilities, etc. meet the requirements of the three types of medical device operation, and conduct on-site inspections if necessary.

• On site inspection: The inspectors will inspect the business premises and warehouses of the enterprise, check whether the facilities and equipment are complete, whether the personnel meet the qualification requirements, and whether the quality management system is effectively operating. For example, checking whether the layout of the warehouse is reasonable, whether the storage conditions meet the requirements of medical devices, verifying the abilities and work experience of key personnel such as quality managers, etc.

• Approval Decision

• Comprehensive evaluation: Based on the results of technical review and on-site verification, the approval department conducts a comprehensive evaluation and forms approval opinion 6.

• Make a decision: For applications that meet the requirements, make a decision to grant permission and issue a Class III medical device business license; Make a decision not to grant permission to applications that do not meet the requirements, and provide a written explanation of the reasons.

• Subsequent management

• Certificate management: Enterprises should properly keep the Class III business license for medical devices, conduct business within the scope of the license, and display the license in a prominent position on product packaging or business premises in accordance with regulations.

• Supervision and Inspection: Regulatory authorities will regularly supervise and inspect certified enterprises to ensure that they continue to comply with regulatory requirements, such as checking whether their business activities are compliant and whether their quality management system is effectively maintained.