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Latest Regulations

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Notice on Public Solicitation of Opinions on the Guiding Principles for the Registration and Review of Qualitative, Quantitative, and In Vitro Release Studies of Medicinal Device Combination Medical Devices (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210916 Registration & Filing 2021-09-16 2021-09-16
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Combination Product
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration Review of Pharmaceutical Device Combination Medical Devices (Draft for Soliciting Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210726 Registration & Filing 2021-07-26 2021-07-26
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Guidelines Combination Product
Guidelines for Technical Review of Registration of Vision Screening Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第42号-f1 Registration & Filing 2021-06-29 2021-06-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for Technical Review of Breast X-ray System Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第42号-f2 Registration & Filing 2021-06-29 2021-06-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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 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
Guiding Principles for Technical Review of Citric Acid Disinfectant Registration
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210508-f2 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 Disposable Sterile Closure Clamp Registration
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210508-f4 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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