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Latest Regulations

1882  Results

Guiding principles for registration and review of anti cyclic citrullinated peptide antibody detection reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第22号-f13 Registration & Filing 2023-07-07 2023-07-06
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of Gram Positive Bacterial Identification Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第22号-f14 Registration & Filing 2023-07-07 2023-07-06
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Matters Related to Changes in the Instruction Manual of Some In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注函〔2023〕349号 Pre-Market 2023-07-07 2023-06-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice on Issuing the Guiding Principles for Clinical Evaluation, Registration and Review of Same Variety of Intervertebral Fusion Cages by the Equipment Review Center of the National Medical Products Administration (No. 20, 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第20号 Registration & Filing 2023-06-28 2023-06-26
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Announcement on Adjusting the Management of Human Genetic Resources
Regulation No. Product LifeCycle Issued Date Implemented Date MOST-20230627 Clinical Evaluation 2023-06-27 2023-06-21
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Announcements IVD
Guidelines for Clinical Evaluation, Registration and Review of Absorbable Surgical Sutures of the Same Variety (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230625-f1 Registration & Filing 2023-06-25 2023-06-21
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Clinical Evaluation, Registration and Review of Disposable Blood Dialyzers (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230625-f3 Registration & Filing 2023-06-25 2023-06-21
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Key Points for Technical Evaluation of Abdominal Endoscopic Surgery Systems (Revised in 2023) (No. 18, 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第18号 Registration & Filing 2023-06-19 2023-06-19
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device
Guidelines for Filling in Application Materials for Classification and Definition of Medical Devices (Trial)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20230614 Pre-Market 2023-06-14 2023-06-14
Status Issued By Level of Legal Effect Product Category Valid National Health … Work Documents IVD
Guiding Principles for Registration Review of Medical Needleless Syringes
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第17号-f1 Registration & Filing 2023-06-06 2023-06-02
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
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