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)。
tion agency: State Food and Drug Administration Place ofacceptance: The Administrative Acceptance Service Center of theState Food and Drug Administration 3. Event changes: If thecontents listed in the registration certificate of medical deviceproducts change, the certificate holder shall, within 30 days fromthe date of the change, apply for the change procedures orre-registration. 4. Validity period and extension of the license:The medical device product registration certificate is valid forfour years. The certificate holder shall apply for re-registrationwithin 6 months before the expiration of the validity period of theproduct registration certificate. According to the currentregulations, the approval time limit of production license is 30working days, and the approval time limit