准备阶段
· 明确要求：详细了解当地食品药品监督管理部门对于医疗器械二、三类经营许可证办理的具体要求，包括人员资质、场地条件、质量管理体系等方面的规定234.
· 准备材料：
· 填写《医疗器械经营企业许可证申请表》124.
· 提供营业执照副本及复印件，确保经营范围涵盖相关医疗器械经营内容124.
· 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124.
· 准备房产证明、房屋租赁证明等，以证明企业经营场所和仓库的产权或使用权124.
· 提供企业负责人、质量管理人的简历124.
· 制定医疗器械质量管理档案或表格，涵盖采购、验收、储存、销售、售后服务等环节的管理要求246.
· 出具申请材料真实性的自我保证声明124.
· 根据企业具体情况，可能还需提供其他相关材料，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14.
申请提交
· 将准备好的完整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24.
受理审查
· 相关部门收到申请后，会在规定时间内对申请材料进行审查24 ：
· 检查材料的完整性，确保所有必需的文件和信息都已提供。
· 核实材料的真实性，包括证明文件的有效性、人员资质的真实性等。
· 审查企业是否符合二、三类医疗器械经营许可证的办理条件，如人员资质是否达标、经营场所和仓库条件是否满足要求、质量管理体系是否健全等方面4.
Preparation stage
·Clear requirements: Detailedunderstanding of the specific requirements of the local food anddrug supervision and management department for the application ofClass II and III business licenses for medical devices, includingpersonnel qualifications, site conditions, quality managementsystems, and other regulations
·Preparationmaterials:
·Fill out the "Application Formfor Medical Device Business License" 124
·Provide a copy and photocopyof the business license to ensure that the business scope coversrelevant medical device operations
·Qualification documents suchas identity certificates, educational background or professionaltitle certificates of legal representatives, enterprise leaders,and quality managers
·Prepare property certificates,rental certificates, etc. to prove the ownership or use rights ofthe business premises and warehouses
·Provide resumes of companyleaders and quality management personnel
·Develop quality managementfiles or forms for medical devices, covering managementrequirements for procurement, acceptance, storage, sales,after-sales service, and other processes
·Provide a self assurancestatement on the authenticity of the applicationmaterials
·According to the specificsituation of the enterprise, other relevant materials may need tobe provided, such as the supplier's business license, permit, andauthorization letter; Quality management documents; Proof of officespace and warehouse that meet the requirements for medical deviceoperation; Articles of Association and Shareholders' MeetingResolutions; Financial personnel ID card and work permit, etc.14
Applicationsubmission
·Submit the prepared completeapplication materials to the food and drug supervision andmanagement department at the city level where the district islocated
Acceptance review
·After receiving theapplication, the relevant departments will review the applicationmaterials within the prescribed time
·Check the integrity of thematerials and ensure that all necessary documents and informationhave been provided.
·Verify the authenticity ofmaterials, including the validity of supporting documents, theauthenticity of personnel qualifications, etc.
·Review whether the enterprisemeets the requirements for obtaining Class II and III medicaldevice operating licenses, such as whether the personnelqualifications meet the standards, whether the operating premisesand warehouse conditions meet the requirements, and whether thequality management system is sound