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The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Key Points and Determination Principles for Supervision and Inspection of Clinical Trial Institutions of Medical Devices (Draft for Solicitation of Opinions)"
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20230407 Clinical Evaluation 2023-04-07 2023-04-04
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD
Notice on Issuing the 2023 National Medical Device Sampling Product Inspection Plan by the Comprehensive Department of the National Medical Products Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管〔2023〕28号 Supervision & Inspection 2023-03-31 2023-03-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration Review of Ultrasound Soft Tissue Surgical Equipment (Revised in 2023) (No. 4 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第4号 Registration & Filing 2023-03-31 2023-03-17
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Summary of the results of the first classification and definition of medical device products in 2023
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20230330 Pre-Market 2023-03-30 2023-03-30
Status Issued By Level of Legal Effect Product Category Valid Center for … Work Documents Non-Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of Intraperitoneal Endoscopic Surgery Systems Part 1: Surgical Instruments (No. 5, 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第5号 Registration & Filing 2023-03-23 2023-03-22
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice of the National Health Commission on Issuing the Catalogue of Large Medical Equipment Configuration License Management (2023)
Regulation No. Product LifeCycle Issued Date Implemented Date 国卫财务发〔2023〕7号 Usage 2023-03-21 2023-03-03
Status Issued By Level of Legal Effect Product Category Valid National Heath … Work Documents Medical Device
Policy Interpretation of the Catalogue for License Management of Large Medical Equipment Configuration (2023)
Regulation No. Product LifeCycle Issued Date Implemented Date NHC-20230321 Usage 2023-03-21 2023-03-21
Status Issued By Level of Legal Effect Product Category Valid National Heath … Work Documents Medical Device
Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Work Rules of the Medical Device Classification Technical Committee of the National Medical Products Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注〔2023〕23号 Pre-Market 2023-03-14 2023-03-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Classification Catalogue of In Vitro Diagnostic Reagents (Revised Draft for Comments)"
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20230314 Pre-Market 2023-03-14 2023-03-08
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD
Guiding Principles for Registration Review of Dental Adhesive Products (No. 3 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第3号-f1 Registration & Filing 2023-03-09 2023-03-07
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
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