朝阳安慧桥北京医疗器械二类备案医疗器械三类经营许可证专业办理包下证Zui详细的教程快来看

受理地点：国家食品药品监督管理局行政受理服务中心

3.事项变更：

医疗器械产品注册证书所列内容发生变化的，持证单位应当自发生变化之日起30日内，申请办理变更手续或者重新注册。

4.许可证件有效期与延续：

医疗器械产品注册证书有效期四年。持证单位应当在产品注册证书有效期届满前6个月内，申请重新注册。

现行法规规定，生产许可证审批时限30个工作日，产品注册证审批时限90个工作日，但实际的产品注册证审批时间大概在8-10个月(顺利的话)。

review: after the administrative acceptance service centeraccepts the application, the application materials will be sent tothe medical device technical review center for technical review.the technical review includes product testing and expert review,and the technical review shall not exceed 60 days. however, afterthe expert evaluation, if the applicant is put forward therectification opinion, the applicant's rectification time will notbe included in the licensing time limit. (iii) license decision:after receiving the data of the technical review center, the statefood and drug administration makes a decision to register or not toregister within 30 days. if it fails to register, it shall explainthe reasons in writing. (iv) service: within 10 days from the dateof