新办理一家三类医疗器械公司的步骤是什么呢？
1.公司注册：需要进行公司注册，注册时应将公司的经营范围与医疗器械经营范围相符，并具备相应的注册资金、地址、人员等条件。
2.设立医疗器械经营部门：在公司内设立专门的医疗器械经营部门，负责医疗器械的采购、销售、仓储和售后服务等工作。
3.聘请人员：聘请具有相关医疗器械经营经验的人员，如负责人、注册人员、经营管理人员、技术人员等。
4.提交申请材料：提交申请材料包括医疗器械经营许可证申请表、医疗器械经营许可证颁发范围的说明、公司营业执照、组织机构代码证、税务登记证法人代表身份证、医疗器械经营负责人和技术人员的聘书、企业的药品经营质量管理规范制度及其实施情况、医疗器械的采购渠道、销售情况等。
申请办理三类医疗器械许可证必须提前准备的原材料
（1）企业营业执照；
（2）公司章；
（3）房屋产权证明、租赁协议；
（4）法定代表人、主要负责人、品质管理员的身份、毕业证等证明材料；
（5）经营地平面设计图，仓库平面设计图。
注意事项：
（1）场所和仓库总面积规定：与经营地企业规模相一致。
（2）品质管理员规定：专科本科以上学历或是初级左右职称，理应具备3年左右医疗器械经营品质管理方面亲身经历。
（3）品质管理员技术规定：医疗机械有关技术，例如：医药学、药理学、生物技术、护理等。
5.现场审核：申请材料提交后，医疗器械监督管理部门将对企业进行现场审核，包括场地、人员、质量管理、医疗器械采购、销售等方面的审核。
6.审核通过后，医疗器械监督管理部门将颁发医疗器械经营许可证。
申请三类医疗器械经营许可证需要满足相关的资质要求和管理要求，申请过程比较复杂，建议企业在申请前了解相关政策法规，以及咨询的医疗器械代办公司或律师事务所，提高申请成功率
What are the steps to establish a new Class III medical devicecompany?
1. Company registration: Firstly, a company registration isrequired, which should match the business scope of the company withthat of medical devices, and have the corresponding registeredcapital, address, personnel, and other conditions.
2. Establish a medical device operation department: Set up adedicated medical device operation department within the company,responsible for the procurement, sales, warehousing, andafter-sales service of medical devices.
3. Hiring personnel: Hire personnel with relevant medical deviceoperation experience, such as responsible persons, registeredpersonnel, management personnel, technical personnel, etc.
4. Submit application materials: Submit application materialsincluding the Medical Device Business License Application Form, anexplanation of the scope of issuance of the Medical Device BusinessLicense, the company's business license, organization codecertificate, tax registration certificate, legal representative'sID card, appointment letters for the person in charge of medicaldevice operation and technical personnel, the company's drugoperation quality management standard system and itsimplementation, medical device procurement channels, salessituation, etc.
Raw materials that must be prepared in advance for applying fora Class III medical device license
(1) Enterprise business license;
(2) Company seal;
(3) Proof of property ownership and lease agreement;
(4) Proof materials such as the identity and graduationcertificate of the legal representative, main person in charge, andquality manager;
(5) Business floor plan and warehouse floor plan.
matters needing attention:
(1) The total area of the venue and warehouse shall beconsistent with the scale of the enterprise in the operatinglocation.
(2) Quality Manager Regulations: Applicants should have abachelor's degree or above or a junior professional title, andshould also have at least 3 years of personal experience in medicaldevice operation quality management.
(3) Quality Manager Technical Professional Regulations:Technical majors related to medical machinery, such as medicine,pharmacology, biotechnology, nursing, etc.
5. On site audit: After the application materials are submitted,the medical device supervision and management department willconduct an on-site audit of the enterprise, including audits of thevenue, personnel, quality management, medical device procurement,sales, and other aspects.
After the review is approved, the medical device supervision andmanagement department will issue a medical device businesslicense.
Applying for a Class III medical device business licenserequires meeting relevant qualification and managementrequirements, and the application process is quite complex. It isrecommended that companies understand relevant policies andregulations, as well as consult medical device agencies or lawfirms, before applying to improve the success rate of theapplication