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Latest Regulations

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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
Announcement of the National Medical Products Administration on the Comprehensive Implementation of Electronic Registration Certificates for Medical Devices (No. 91 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第91号 Registration & Filing 2022-10-26 2022-10-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Guidelines for Registration Review of Creatine Kinase Testing Reagents (Revised 2023) (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-28 Registration & Filing 2022-10-25 2022-10-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Announcement on the Arrangement of On site Consultation Services in the Administrative Acceptance Service Hall of the National Medical Products Administration (No. 316)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第316号 Registration & Filing 2022-10-18 2022-10-18
Status Issued By Level of Legal Effect Product Category Valid Administrative Acceptance … Announcements Combination Product
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