o submit the application materials to the relevant departments;(2) Relevant departments shall accept the application of theapplicant; (3) Investigate the actual site and audit the products;(4) Grant the issuance of a class III medical device license. 2.Legal basis: Article 14 of the Regulations on the Supervision andAdministration of Medical Devices As for the registration of ClassII and III medical devices, the following materials shall besubmitted: (1) Product risk analysis data; (2) Technicalrequirements for the products; (3) Product inspection report; (4)Clinical evaluation data; (5) Product specification and labelsamples; (6) quality management system documents related to productdevelopment and production; (7) other materials required to provethe safety and effectiveness of the product. 4, go to theIndustrial and commercial Bureau for additional items, is the needto take the staff of the Industrial and commercial Bureau to checkthe warehouse, you had better clean up the warehouse, and then getthe "medical device business enterprise license application form"and fill in, and bring all the relevant qualifications of theenterprise, but also need to bring the relevant information ofquality personnel. 5. The business license of Class III medicaldevices needs to be handled directly by the food and drugsupervision and administration department of the municipal people'sgovernment, and shall be reviewed within 30 days after receivingthe materials. If the relevant regulations are met, the bus
人提交申請資料到相關部門；
（2）相關部門受理申請人的申請肋乍；
（3）到實際場地進行勘察以及對產品進行審核鹅颊；
（4）準予頒發(fā)三類醫(yī)療器械許可證。
2墓造、法律依據：《醫(yī)療器械監(jiān)督管理條例》第十四條
第一類醫(yī)療器械產品備案和申請第二類堪伍、第三類醫(yī)療器械產品注冊，應當提交下列資料：
（一）產品風險分析資料滔岳；
（二）產品技術要求；
（三）產品檢驗報告挽牢；
（四）臨床評價資料谱煤；
（五）產品說明書以及標簽樣稿；
（六）與產品研制禽拔、生產有關的質量管理體系文件刘离；
（七）證明產品安全、有效所需的其他資料睹栖。
1硫惕、4、去工商局辦理增項宜切，是需要帶著工商局的工作人員來查看庫房的察贵，你**把庫房收拾一下，領取《醫(yī)療器械經營企業(yè)許可申請表》并填寫孤咏，并把企業(yè)相關資質全部帶上旋喊，還需要帶上質量人員的相關資料。
2山刨、5哲陷、三類醫(yī)療器械經營許可證，需要直接去市級人民政府食品藥品監(jiān)督管理部門辦理随港，在接受資料后的30天內進行審核墙议，如果符合相關規(guī)定，就可以頒發(fā)三類醫(yī)療器械經營許可證溃登。
醫(yī)療企業(yè)經營許可證一
iness license of Class III medical devices can be issued.Medical enterprise operation license 1
