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Latest Regulations

1153  Results

Guiding principles for clinical trials of in vitro diagnostic reagents using samples from human biological sample banks
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第40号-f2 Registration & Filing 2022-11-24 2022-11-24
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guidelines for Clinical Evaluation, Registration and Review of Microsatellite Instability (MSI) Detection Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第40号-f3 Registration & Filing 2022-11-24 2022-11-24
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration Review of Additive Manufacturing Intervertebral Fusion Cages (No. 39 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第39号 Registration & Filing 2022-11-14 2022-11-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice on Consultation on Digital Authentication (CA) Certificate of Medical Device Registration Electronic Declaration Information System
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221114-1 Registration & Filing 2022-11-14 2022-11-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Guiding Principles for Registration Review of Breast Implant Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221108-f2 Registration & Filing 2022-11-08 2022-11-08
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Main Raw Materials for In Vitro Diagnostic Reagents (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221101-f1 Registration & Filing 2022-11-01 2022-11-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for the Registration and Review of Nucleic Acid Testing and Typing Reagents for Herpes Simplex Virus (HSV) (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221101-f2 Registration & Filing 2022-11-01 2022-11-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of Quantitative Detection Reagents for Tumor Markers (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221101-f3 Registration & Filing 2022-11-01 2022-11-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of Drug Abuse Testing Reagents (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221101-f4 Registration & Filing 2022-11-01 2022-11-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Medical Device Optical Radiation Safety (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221027 Registration & Filing 2022-10-27 2022-10-27
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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