门头沟潭柘寺医疗器械三类经营许可证二类备案专业办理快捷包下证

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。

对申请材料的要求：

1、经营企业提交的《医疗器械经营企业许可证申请表》应有法定代表人签字或加盖企业公章；

2、《医疗器

1) The applicant shall submit 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) 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; (7) other materials required to prove the safety and effectiveness of the product. Requirements for the application materials: 1. The Application Form for Medical Device Business Enterprise License submitted by the operating enterprise shall be signed by the legal representative or affixed with the official seal of the enterprise; 2. Medical devic