海淀厂洼医疗器械三类经营许可证二类备案专业办理快捷包下证
- 供应商
- 北京星期三企业管理咨询有限公司业务部
- 认证
- 医疗器械三类
- 注册
- 医疗器械二类
- 注册
- 注册公司
- 网络销售备案
- 手机号
- 15501182773
- 联系人
- 马胜辉
- 所在地
- 北京市海淀区清河嘉园东区甲1号楼11层1124
- 更新时间
- 2023-11-04 00:00
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;
(七)证明产品安全、有效所需的其他资料。
设立医疗器械经营部门:在公司内设立专门的医疗器械经营部门,负责医疗器械的采购、销售、仓储和售后服务等工作。
聘请专业人员:聘请具有相关医疗器械经营经验的专业人员,如负责人、注册人员、经营管理人员、技术人员等。
提交申请材料:提交申请材料包括医疗器械经营许可证申请表、医疗器械经营许可证颁发范围的说明、公司营业
w to handle the business license 1. class iii medical devicebusiness license is as follows: (1) the applicant submits theapplication materials to the relevant departments; (2) the relevantdepartments accept the application of the applicant's application;(3) investigate the actual site and review the products; (4) grantthe issuance of the class iii medical device license.2. legalbasis: article 14 of the regulations on supervision andadministration of medical devices for the filing of class i medicaldevices and application for the registration of class ii and iiimedical devices shall submit the following materials: (1) productrisk analysis data; (2) technical re (3) product; (3)product inspection report; (4) clinical evaluation data; (5)product instructions and label samples; (6) managementsystem documents related to product development and production; (7)other materials required to prove the safety and effectiveness ofthe product. set up a medical device business department: set up aspecial medical device business department in the company to beresponsible for the procurement, sales, storage and after-salesservice of medical devices. professionals: hire professionals withrelevant medical device business experience, such as responsibleperson, registered personnel, management personnel, technicalpersonnel, etc. application materials for submission: theapplication materials include the application form for medicaldevice business license, the description of the scope of medicaldevice business license, and the company's business
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