办理流程
1. 准备材料347：
· 《医疗器械经营企业许可证申请表》。
· 营业执照副本及复印件。
· 法定代表人、企业负责人、质量负责人的身份证明、学历或者职称证明等资质材料。
· 房产证明、房屋租赁证明等，证明企业经营场所和仓库的产权或使用权。
· 企业负责人、质量管理人的简历。
· 医疗器械质量管理档案或表格。
· 申请材料真实性的自我保证声明。
· 其他相关材料，如供应商营业执照、许可证及授权书；质量管理文件；符合医疗器械经营要求的办公场地及仓库证明；公司章程、股东会决议；财务人员身份证和上岗证等。
2. 提交申请：将准备好的申请材料提交给所在地设区的市级食品药品监督管理部门37.
3. 受理审查37：
· 相关部门受理申请后，会在规定时间内对申请材料进行审查。
· 审查内容包括材料的完整性、真实性，以及企业是否符合二、三类医疗器械经营许可证的办理条件，如人员资质、经营场所和仓库条件、质量管理体系等方面是否达标。
4. 现场勘察：相关部门会安排工作人员到企业的经营场所和仓库进行实地勘察，核实场所的实际情况与申请材料中描述的是否一致，包括面积、布局、设施设备等是否符合要求37.
5. 审核与批准3：
· 根据审查和现场勘察的结果，相关部门领导审批相关资料，决定是否给予企业发放经营许可证。
· 对于符合规定条件的，准予许可并发给医疗器械经营许可证；对不符合规定条件的，不予许可并书面说明理由。
6. 公示与领证：如果申请通过审评，在相关网站上对企业相关信息进行公示，公示无异议的则通知企业领取医疗器械经营许可证3.
在医疗器械行业中，取得相应的经营许可证和销售资质是开展业务的重要一环。北京朝阳区作为科技创新的高地，吸引了众多医疗器械企业。在这样的背景下，北京中盛启诚科技有限公司推出了的医疗器械二、三类经营许可证代理服务，旨在帮助创业者和企业快速、高效地完成相关资质申请。本文将从多个角度解析这一服务的优势及其重要性，助您深入了解医疗器械行业的相关知识。
Handling process
1. Prepare Material347:
·Application Form for MedicalDevice Business License.
·Copy and photocopy of businesslicense.
·Proof of identity, educationalbackground or professional title, and other qualification materialsfor the legal representative, enterprise leader, and qualitymanager.
·Property certificates, rentalcertificates, etc., prove the ownership or use rights of theenterprise's business premises and warehouses.
·Resume of enterprise leaderand quality management personnel.
·Medical device qualitymanagement records or forms.
·Self assurance statement onthe authenticity of application materials.
·Other relevant materials, suchas supplier's business license, permit, and authorization letter;Quality management documents; Proof of office space and warehousethat meet the requirements for medical device operation; Articlesof Association and Shareholders' Meeting Resolutions; Financialpersonnel ID card and work permit, etc.
2. Submit application: Submitthe prepared application materials to the food and drug supervisionand management department at the city level where the district islocated
3. Acceptance review37:
·After the relevant departmentsaccept the application, they will review the application materialswithin the prescribed time.
·The review includes thecompleteness and authenticity of the materials, as well as whetherthe enterprise meets the requirements for obtaining Class II andIII medical device operating licenses, such as personnelqualifications, operating premises and warehouse conditions, andwhether the quality management system meets thestandards.
4. On site inspection: Relevantdepartments will arrange staff to conduct on-site inspections ofthe company's business premises and warehouses to verify whetherthe actual situation of the premises is consistent with thedescription in the application materials, including whether thearea, layout, facilities and equipment meet therequirements
5. Review and Approval3:
·Based on the results of thereview and on-site investigation, the relevant department leadersapprove the relevant materials and decide whether to issue abusiness license to the enterprise.
·For those who meet theprescribed conditions, permission shall be granted and a medicaldevice business license shall be issued; Those who do not meet theprescribed conditions will not be allowed and the reasons will beexplained in writing.
6. Publicity and LicenseIssuance: If the application passes the review, the relevantinformation of the enterprise will be publicized on the relevantwebsite. If there are no objections to the publicity, theenterprise will be notified to obtain the medical device businesslicense
Obtaining the correspondingbusiness license and sales qualification is an important part ofconducting business in the medical device industry. As a highlandof technological innovation, Haidian District in Beijing hasattracted numerous medical device companies. In this context,Beijing Zhongsheng Qicheng Technology Co., Ltd. has launched amedical device business license agency service for Class II andIII, aimed at helping entrepreneurs and enterprises quickly andefficiently complete relevant qualification applications. Thisarticle will analyze the advantages and importance of this servicefrom multiple perspectives, helping you gain a deeper understandingof the relevant knowledge in the medical deviceindustry.