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Latest Regulations

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Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Application of Shelf Life of Passive Implantable Medical Devices (Revised in 2021) (Draft for Soliciting Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210610-1 Registration & Filing 2021-06-10 2021-06-10
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Carrying out Information Confirmation of Medical Device Registration Certificate and Its Attachments (No. 9 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2021年第9号 Registration & Filing 2021-06-04 2021-06-04
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Announcement of the National Medical Products Administration on Implementing the Regulations on the Supervision and Administration of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第76号 Registration & Filing 2021-05-31 2021-05-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Format of Electronic Registration Certificate for Medical Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210525-1-f1 Registration & Filing 2021-05-25 2021-05-25
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents Medical Device
Format of Electronic Registration Certificate for Medical Devices (In Vitro Diagnostic Reagents) (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210525-1-f2 Registration & Filing 2021-05-25 2021-05-25
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD
Format of electronic registration change document for medical devices (draft for soliciting opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210525-1-f3 Registration & Filing 2021-05-25 2021-05-25
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents Medical Device
Format of electronic registration change document for medical devices (in vitro diagnostic reagents) (draft for soliciting opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210525-1-f4 Registration & Filing 2021-05-25 2021-05-25
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Disinfection Caps for Infusion Connections (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210519 Registration & Filing 2021-05-19 2021-05-19
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Technical Review of Dental Glass Ionic Cement Registration
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210508-f1 Registration & Filing 2021-05-08 2021-04-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for Technical Review of Registration of Needles for Disposable Injection Pens
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210508-f3 Registration & Filing 2021-05-08 2021-04-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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