西城西直门北京医疗器械二类备案医疗器械三类经营许可证用心服务全程保密周期短下证快

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)。

holder shall, within 30 days from the date of the change, applyfor the change procedures or re-registration. 4. validity periodand extension of the license: the medical device productregistration certificate is valid for four years. the certificateholder shall apply for re-registration within 6 months before theexpiration of the validity period of the product registrationcertificate. according to the current regulations, the approvaltime limit of production license is 30 working days, and theapproval time limit of product registration certificate is 90working days, but the actual approval time of product registrationcertificate is about 8-10 months (if it goes well).