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Latest Regulations

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Establish a project team evaluation system for high-quality, efficient, and scientific evaluation
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200828-3 Registration & Filing 2020-08-28 2020-08-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Cryptococcal Antigen Detection Reagent Registration (Draft for Soliciting Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200821-3 Registration & Filing 2020-08-21 2020-08-21
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Technical Review of Registration of Nitrous Acid Inhalation Sedative and Analgesic Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第49号 Registration & Filing 2020-07-20 2020-07-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Six Guiding Principles for Registration Technology Review of Disposable Breast Positioning Silk
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第48号-f1 Registration & Filing 2020-07-09 2020-07-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Six Guiding Principles for Registration Technology Review of Dural (Spinal) Membrane Patches
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第48号-f2 Registration & Filing 2020-07-09 2020-07-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Six Guiding Principles for Registration Technology Review, including the Registration Technology Review of Customized Personalized Bone Implants Equivalent Model
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第48号-f3 Registration & Filing 2020-07-09 2020-07-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Six Guiding Principles for Registration Technical Review of Finite Element Analysis Data of Orthopedic Metal Implants
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第48号-f4 Registration & Filing 2020-07-09 2020-07-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Six Registration Technical Review Guiding Principles, including Clinical Trial Guidelines for Hernia Repair Patches
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第48号-f5 Registration & Filing 2020-07-09 2020-07-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Six Registration Technical Review Guidelines, including the Guidelines for Animal Experimental Research on Bioabsorbable Coronary Artery Drug eluting Stents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第48号-f6 Registration & Filing 2020-07-09 2020-07-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Combination Product
Notice on Matters Related to Changes in Registration Information of Registration Applicants
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200707-3 Registration & Filing 2020-07-07 2020-07-07
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
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