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Latest Regulations

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Guidelines for registration and review of biodegradable magnesium metal orthopedic implants
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第4号-f3 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guiding principles for the registration and review of microcatheters
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第4号-f4 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guiding Principles for Registration Review of Disposable High Pressure Imaging Syringes and Accessories
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第4号-f1 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guiding Principles for Registration Review of Metal Orthopedic Plate Internal Fixation System Products (Revised in 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第4号-f2 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Publicly Soliciting Opinions on the Guiding Principles for Registration and Review of CT Imaging Assisted Detection Software for Pulmonary Nodules
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220112 Registration & Filing 2022-01-12 2022-01-10
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for registration review of fluorescence immunoassay analyzers
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第104号-f1 Registration & Filing 2021-12-28 2021-12-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guiding principles for registration and review of net atomizers
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第104号-f2 Registration & Filing 2021-12-28 2021-12-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for registration and review of medical diagnostic X-ray equipment containing pediatric applications
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第104号-f3 Registration & Filing 2021-12-28 2021-12-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for registration and review of ultrasound transcranial Doppler blood flow analyzers
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第104号-f4 Registration & Filing 2021-12-28 2021-12-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for registration and review of anti Mullerian hormone assay reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第104号-f14 Registration & Filing 2021-12-28 2021-12-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
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