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)。

ation 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 certificate. According to the current regulations, the approval time limit of production license is 30 working days, and the approval time limit of p