西城西四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

（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；。

9、凡申请材料需提交复印件的，申请人（单位）须在复印件上注明“此复印件与原件相符”字样或者文字说明，注明日期，加盖单位公章；个人申请的须签字

10、申请材料应完整、清晰、签字，并逐份加盖公章，所有申请表格电脑打字

申请人隐瞒有关情况或者提供虚假材料的，省、自治区、直辖市（食品）药品监督管理部门或者接受委托的设区的市级（食品）药品监督管理机构对申请不予受

; (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 and Administration of Medical Devices As for the registration of Class II and III medical devices, the following materials shall be submitted: (1) Product risk analysis data; (2) Technical requirements for the products; (3) Product inspection report; (4) Clinical evaluation data; (5) Product specification and label samples; (6) quality management system documents related to product development and production; 9. If the application materials need to be submitted, the applicant (unit) shall indicate the words "the copy matches the original" on the copy, indicate the date and stamp the official seal of the unit; the individual application shall be signed 10. The application materials should be complete, clear and signed, and stamped with the official seal. All the application forms should be typed by computer Where the applicant conceals the relevant information or provides false materials, the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government or the entrusted (food) drug regulatory agency of the entrusted city divided into districts shall not accept the application