（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)。

nistrative license decision shall be made within 90 days from the date of acceptance. 2. Implementing agencies: Implementation agency: State Food and Drug Administration Place of acceptance: The Administrative Acceptance Service Center of the State Food and Drug Administration 3. Event changes: If the contents listed in the registration certificate of medical device products change, the certificate holder shall, within 30 days from the date of the change, apply for the change procedures or re-registration. 4. Validity period and extension of the license: The medical device product registration certificate is valid for four years. The certificate holder shall apply for re-registration within 6 months before the expiration of the validity period of the product registration