丰台嘉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
(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;申请人隐瞒有关情况或者提
办理三类医疗器械经营许可证的办理流程:
1.向食品药品监督管理局提交医疗器械经营许可证申请材料;
2.食品药品监督管理局数据形式审查;
3.数据正式受理;
4.有关部门的行政审查;
5.现场评价;
6.有关部门
ense.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for the registration of Class II and Class III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product instructions and label samples; (6) the quality management system documents related to product development and production; the applicant conceals relevant information Procedures for handling third III medical device business license: 1. Submit application materials for medical device business license to the Food and Drug Administration; 2. examination of data form of the Food and Drug Administration; 3. Official acceptance of data; 4. administrative review of relevant departments; 5. On-site evaluation; 6. Relevant departments