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Latest Regulations

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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 Public Solicitation of Opinions on the Guiding Principles for Technical Review of Changes in License Matters for In Vitro Diagnostic Reagents (Second Edition Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200701-2 Registration & Filing 2020-07-01 2020-07-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Notice of the National Medical Products Administration on the Guiding Principles for Technical Review of Two Registration Technologies, including in Vitro Synchronized Reflexing Products
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第42号-f1 Registration & Filing 2020-06-29 2020-06-23
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on the Guiding Principles for the Examination of Two Registration Technologies, including Extracorporeal Percutaneous Pacing Products
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第42号-f2 Registration & Filing 2020-06-29 2020-06-23
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 the Establishment and Characterization of Evaluation Methods for Unknown Leachable Substances in Medical Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200624-2 Registration & Filing 2020-06-24 2020-06-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of 8 Registration Technologies, including Heat and Humidity Exchangers
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第39号-f1 Registration & Filing 2020-06-17 2020-06-09
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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