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Latest Regulations

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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
Announcement of the National Medical Products Administration on the Management Categories of Medical Sodium Hyaluronate Products (No. 103 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第103号 Pre-Market 2022-11-14 2022-11-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Interpretation of Announcement No. 103 of 2022 on the Management Categories of Medical Sodium Hyaluronate Products
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20221114-3 Pre-Market 2022-11-14 2022-11-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents 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
Guidelines for Writing Instructions for In Vitro Diagnostic Reagents (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221101-f5 Pre-Market 2022-11-01 2022-11-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
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