2.實(shí)施機關(guān)：

實(shí)施機關(guān)：國家食品藥品監督管理局

受理地點(diǎn)：國家食品藥品監督管理局行政受理服務(wù)中心

3.事項變更：

醫療器械產(chǎn)品注冊證書(shū)所列內容發(fā)生變化的，持證單位應當自發(fā)生變化之日起30日內，申請辦理變更手續或者重新注冊。

4.許可證件有效期與延續：

醫療器械產(chǎn)品注冊證書(shū)有效期四年。持證單位應當在產(chǎn)品注冊證書(shū)有效期屆滿(mǎn)前6個(gè)月內，申請重新注冊。

現行法規規定，生產(chǎn)許可證審批時(shí)限30個(gè)工作日，產(chǎn)品注冊證審批時(shí)限90個(gè)工作日，但實(shí)際的產(chǎn)品注冊證審批時(shí)間大概在8-10個(gè)月(順利的話(huà))。

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