疗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;
(五)产品说明书以及标签样稿;
(六)与产品研制、生产有关的质量管理体系文件;
(七)证明产品安全、有效所需的其他资料。
(1)提交医疗器械经营企业许可证申请表,法定代表人签字或加盖企业公章;
(2)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件和校验原件;
(3)企业质量管理负责人的身份证、学历或
medical equipment is handled as follows: (1) The applicant shallsubmit the application materials to the relevant departments; (2)Relevant departments shall accept the application of the applicant;(3) Investigate the actual site and audit the products; (4) Grantthe issuance of a class III medical device license. 2. Legal basis:Article 14 of the Regulations on the Supervision and Administrationof Medical Devices As for the registration of Class II and III, thefollowing materials shall be submitted: (1) Product risk analysisdata; (2) Technical requirements for the products; (3) Productinspection report; (4) Clinical evaluation data; (5) Productspecification and label samples; (6) quality management systemdocuments related to product development and production; (7) othermaterials required to prove the safety and effectiveness of theproduct. (1) Submit the application form for the license of themedical device trading enterprise, signed by the legalrepresentative or affix the official seal of the enterprise; (2)The copy of the pre-approval certificate of enterprise name or thebusiness License issued by the administrative department forindustry and commerce; (3) The id card, education background or ofthe person in charge of the enterprise quality management