新辦理一家三類醫(yī)療器械公司的步驟是什么呢？
1.公司注冊(cè)：需要進(jìn)行公司注冊(cè)，注冊(cè)時(shí)應(yīng)將公司的經(jīng)營(yíng)范圍與醫(yī)療器械經(jīng)營(yíng)范圍相符，并具備相應(yīng)的注冊(cè)資金、地址、人員等條件。
2.設(shè)立醫(yī)療器械經(jīng)營(yíng)部門：在公司內(nèi)設(shè)立專門的醫(yī)療器械經(jīng)營(yíng)部門，負(fù)責(zé)醫(yī)療器械的采購(gòu)、銷售、倉(cāng)儲(chǔ)和售后服務(wù)等工作。
3.聘請(qǐng)人員：聘請(qǐng)具有相關(guān)醫(yī)療器械經(jīng)營(yíng)經(jīng)驗(yàn)的人員，如負(fù)責(zé)人、注冊(cè)人員、經(jīng)營(yíng)管理人員、技術(shù)人員等。
4.提交申請(qǐng)材料：提交申請(qǐng)材料包括醫(yī)療器械經(jīng)營(yíng)許可證申請(qǐng)表、醫(yī)療器械經(jīng)營(yíng)許可證頒發(fā)范圍的說明、公司營(yíng)業(yè)執(zhí)照、組織機(jī)構(gòu)代碼證、稅務(wù)登記證法人代表身份證、醫(yī)療器械經(jīng)營(yíng)負(fù)責(zé)人和技術(shù)人員的聘書、企業(yè)的藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范制度及其實(shí)施情況、醫(yī)療器械的采購(gòu)渠道、銷售情況等。
申請(qǐng)辦理三類醫(yī)療器械許可證必須提前準(zhǔn)備的原材料
（1）企業(yè)營(yíng)業(yè)執(zhí)照；
（2）公司章；
（3）房屋產(chǎn)權(quán)證明、租賃協(xié)議；
（4）法定代表人、主要負(fù)責(zé)人、品質(zhì)管理員的身份、畢業(yè)證等證明材料；
（5）經(jīng)營(yíng)地平面設(shè)計(jì)圖，倉(cāng)庫(kù)平面設(shè)計(jì)圖。
注意事項(xiàng)：
（1）場(chǎng)所和倉(cāng)庫(kù)總面積規(guī)定：與經(jīng)營(yíng)地企業(yè)規(guī)模相一致。
（2）品質(zhì)管理員規(guī)定：?？票究埔陨蠈W(xué)歷或是初級(jí)左右職稱，理應(yīng)具備3年左右醫(yī)療器械經(jīng)營(yíng)品質(zhì)管理方面親身經(jīng)歷。
（3）品質(zhì)管理員技術(shù)規(guī)定：醫(yī)療機(jī)械有關(guān)技術(shù)，例如：醫(yī)藥學(xué)、藥理學(xué)、生物技術(shù)、護(hù)理等。
5.現(xiàn)場(chǎng)審核：申請(qǐng)材料提交后，醫(yī)療器械監(jiān)督管理部門將對(duì)企業(yè)進(jìn)行現(xiàn)場(chǎng)審核，包括場(chǎng)地、人員、質(zhì)量管理、醫(yī)療器械采購(gòu)、銷售等方面的審核。
6.審核通過后，醫(yī)療器械監(jiān)督管理部門將頒發(fā)醫(yī)療器械經(jīng)營(yíng)許可證。
申請(qǐng)三類醫(yī)療器械經(jīng)營(yíng)許可證需要滿足相關(guān)的資質(zhì)要求和管理要求，申請(qǐng)過程比較復(fù)雜，建議企業(yè)在申請(qǐng)前了解相關(guān)政策法規(guī)，以及咨詢的醫(yī)療器械代辦公司或律師事務(wù)所，提高申請(qǐng)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