海淀牡丹园没有人员怎么办北京医疗器械三类经营许可证提供人员库房专业安全包下证

（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；追溯。1、经营企业提交的

8、申请材料真实性的自我保证声明应由法定代表人签字并加盖企业公章，如无公章，则须有法定代表人本人签字或签章。

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；个人申请的须签字或签章。

pplication; (3) investigate the actual site and review theproduct; (4) grant the issuance of a class III medical devicelicense.2. Legal basis: Article 14 of the Regulations onSupervision and Administration of Medical Devices For the filing ofClass I medical devices and the application for the registration ofClass II and III medical devices, the following materials shall besubmitted: (1) product risk analysis data; (2) product technicalrequirements; (3) product inspection report; (4) clinicalevaluation data; (5) product instructions and label samples; (6)quality management system documents related to product developmentand production; traceability.1. Submit it by the operatingenterprise 8. The self-guarantee statement of the authenticity ofthe application materials shall be signed by the legalrepresentative and affixed with the official seal of theenterprise. If there is no official seal, there must be thesignature or signature of the legal representative himself. 9. Ifthe application materials need to be submitted, the applicant(unit) shall indicate the words "this copy is consistent with theoriginal" or the text description on the copy, indicate the dateand st