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Latest Regulations

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Notice on Issuing Guiding Principles for Registration and Review of Motor Neuron Surviving Gene 1 (SMN1) Testing Reagents by the Equipment Review Center of the National Medical Products Administration (No. 44, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第44号 Registration & Filing 2022-11-28 2022-11-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Safety and Efficacy Evaluation of Medical Devices Applied with Nanomaterials Part 3: Biocompatibility/Toxicology Evaluation (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221128-1 Registration & Filing 2022-11-28 2022-11-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Aspergillus Nucleic Acid Testing Reagents (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221128-2 Registration & Filing 2022-11-28 2022-11-28
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 Clinical Trial Registration and Review of Human Immunodeficiency Virus Testing Reagents (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221128-3 Registration & Filing 2022-11-28 2022-11-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for registration review of disposable cardiac fixators
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第41号-f1 Registration & Filing 2022-11-25 2022-11-11
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of Disposable Medical Rinser Products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第41号-f2 Registration & Filing 2022-11-25 2022-11-11
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guiding principles for registration and review of non absorbable surgical sutures
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第41号-f3 Registration & Filing 2022-11-25 2022-11-11
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guidelines for Registration Review of Face Masks, Masks, and Nose Masks for Continuous Positive Pressure Ventilation
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第41号-f4 Registration & Filing 2022-11-25 2022-11-11
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guiding principles for registration review of non bracket orthodontic appliances
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第41号-f5 Registration & Filing 2022-11-25 2022-11-11
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Medical Suture Needles
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第41号-f6 Registration & Filing 2022-11-25 2022-11-11
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
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