(四)送达:
自行政许可决定作出之日起10日内,SFDA行政受理服务中心将行政许可决定送达申请人。
1.承诺时限:自受理之日起,90日内作出行政许可决定。
2.实施机关:
实施机关:国家食品药品监督管理局
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)。
cceptance Service Center shall serve the administrative licensedecision to the applicant. 1. Time limit of commitment: theadministrative license decision shall be made within 90 days fromthe date of acceptance. 2. Implementing agencies: Implementationagency: State Food and Drug Administration Place of acceptance: TheAdministrative Acceptance Service Center of the State Food and DrugAdministration 3. Event changes: If the contents listed in theregistration certificate of medical device products change, thecertificate holder shall, within 30 days from the date of thechange, apply for the change procedures or re-registration. 4.Validity period