西城新街口北京办理医疗器械三类经营许可证没有库房怎么办包下证快捷

（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；。理或者不予核发《医疗器械经营企业许可证》，并给予警告。申请人在1年内不得申请《医疗器械经营企业许可证》。申请人以欺骗、贿赂等不正当手段取得《医疗器械经营企业许可证》的，（食品）药品监督管理部门应当撤销其《医疗器械经营企业许可证》，给予警告，并处1万元以上2万元以下罚款。申请人在3年内不得申请《医疗器械经营企业许可证》。

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；

audit the products; (4) Grant the issuance of a class III medicaldevice license. 2. Legal basis: Article 14 of the Regulations onthe Supervision and Administration of Medical Devices As for theregistration of Class II and III medical devices, the followingmaterials shall be submitted: (1) Product risk analysis data; (2)Technical requirements for the products; (3) Product inspectionreport; (4) Clinical evaluation data; (5) Product specification andlabel samples; (6) quality management system documents related toproduct development and production;The medical Device OperatingEnterprise License shall not be issued and given a warning. Theapplicant shall not apply for the Medical Device BusinessEnterprise License again within one year. Where the applicantobtains the Medical Device Trading Enterprise License by impropermeans of cheating or bribery, the (food) and drug regulatorydepartment shall revoke the Medical Device Trading EnterpriseLicense, give a warning and impose a fine of not less than 10,000yuan but not more than 20,000 yuan. The applicant shall not applyfor the Medical Device Business Enterprise License again within 3years. Procedures for handling the business license of Class IIImedical devices: 1. Submit the application materials for medicaldevice business license to the Food and Drug Administration;