器械经营许可证办理方式如下:
(1)申请人提交申请资料到相关部门;
(2)相关部门受理申请人的申请;
(3)到实际场地进行勘察以及对产品进行审核;
(4)准予颁发三类医疗器械许可证。
2、法律依据:《医疗器械监督管理条例》第十四条
第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册,应当提交下列资料:
(一)产品风险分析资料;
(二)产品技术要求;
(三)产品检验报告;
(四)临床评价资料;
办理三类医疗器械经营许可证的办理流程:
1.向食品药品监督管理局提交医疗器械经营许可证申请材料;
2.食品药品监督管理局数据形式审查;
3.数据正式受理;
4.有关部门的行政审查;
5.现场评价;
6.有关部门的行政决定;
7.制证、发
evice business license are as follows: (1) the applicant submitsthe application materials to the relevant departments; (2) therelevant departments accept the application of the applicant; (3)investigate the actual site and reviews the product; (4) grant theissuance of the third III medical device license.2. Legal basis:Article 14 of the Regulations on supervision and Administration ofMedical Devices and applying for registration of Class II and ClassIII medical devices, the following materials shall be submitted:(1) product risk analysis data; (2) product technical requirements;(3) product inspection report; and (4) clinical evaluation data;Procedures for handling the business license of Class III medicaldevices: 1. Submit application materials for medical devicebusiness license to the Food and Drug Administration; 2.Examination of data form of the Food and Drug Administration; 3.Official acceptance of data; 4. Administrative review of relevantdepartments; 5. On-site evaluation; 6. Administrative decisions ofrelevant departments; 7. License making and issuance