西城西直门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

类医疗器械经营许可证如何办理

1、三类医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；。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

to handle the class of medical device business license 1. Thebusiness license of Class III medical devices is handled asfollows: (1) The applicant shall submit the application materialsto the relevant departments; (2) Relevant departments shall acceptthe application of the applicant; (3) Investigate the actual siteand audit the products; (4) Grant the issuance of a class IIImedical device license. 2. Legal basis: Article 14 of theRegulations on the Supervision and Administration of MedicalDevices As for the registration of Class II and III medicaldevices, the following materials shall be submitted: (1) Productrisk analysis data; (2) Technical requirements for the products;(3) Product inspection report; (4) Clinical evaluation data; (5)Product specification and label samples; (6) quality managementsystem documents related to product development and production;Themedical Device Operating Enterprise License shall not be issued andgiven a warning. The applicant shall not apply for the MedicalDevice Business Enterprise License again within one year. Where theapplicant obtains the "Medical Device Trading Enterprise License"by improper means of cheating or bribery, the (food) and drugregulatory department shall revoke the "Medical Device TradingEnterprise License", give a warning and impose a fine of not lessthan 10,000 yuan but not more than 20,000 yuan. The applicantshall