怀柔雁栖医疗器械三类经营许可证二类备案专业办理快捷包下证

) The applicant shall submit the application materials to therelevant departments; (2) Relevant departments shall accept theapplication of the applicant; (3) Investigate the actual site andaudit 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; (7) other materials required toprove the safety and effectiveness of the product. 4, go to theIndustrial and commercial Bureau for additional items, is the needto take the staff of the Industrial and commercial Bureau to checkthe warehouse, you had better clean up the warehouse, and then getthe "medical device business enterprise license application form"and fill in, and bring all the relevant qualifications of theenterprise, but also need to bring the relevant information ofquality personnel. 5. The business license of Class III medicaldevices needs to be handled directly by the food and drugsupervision and administration department of the municipal people'sgovernment, and shall be reviewed within 30 days after receivingthe materials. If the relevant regulations are met, the businesslicense of Class III medical devices can be issued. There are threetypes of medical enterprise business licenses, among which thefirst class medical device license can be directly handled, theoperation of second class products needs to apply for the recordcertificate of second class medical devices, and the operation ofthird class products needs to apply for the business license ofthird class medical devices.

（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。

1、4、去工商局办理增项，是需要带着工商局的工作人员来查看库房的，你**把库房收拾一下，领取《医疗器械经营企业许可申请表》并填写，并把企业相关资质全部带上，还需要带上质量人员的相关资料。

2、5、三类医疗器械经营许可证，需要直接去市级人民政府食品药品监督管理部门办理，在接受资料后的30天内进行审核，如果符合相关规定，就可以颁发三类医疗器械经营许可证。

医疗企业经营许可证一共有三类，其中办理一类医疗器械许可证可以直接办理，经营二类产品是需要办理二类医疗器械经营备案凭证，经营三类产品则需要办理三类医疗器械经营许可证。