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Latest Regulations

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Notice on Issuing Guiding Principles for Clinical Evaluation, Registration and Review of Medical X-ray Diagnostic Equipment (Class III) of the Same Variety by the Equipment Review Center of the National Medical Products Administration (No. 30, 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第30号 Registration & Filing 2023-08-04 2023-08-03
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Clinical Evaluation and Registration Review of the Same Product of Positron Emission/X-ray Computed Tomography Systems (No. 31, 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第31号 Registration & Filing 2023-08-04 2023-08-03
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Medical Dressing Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20230804 Registration & Filing 2023-08-04 2023-08-04
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines Medical Device
Guidelines for Registration Review of Disposable Membrane Oxygenator (CPB) (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230802-1 Registration & Filing 2023-08-02 2023-08-02
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Registration Review of Dialysate Filters (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230802-2 Registration & Filing 2023-08-02 2023-08-02
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 Guiding Principles for Clinical Evaluation, Registration and Review of Laser Therapy Equipment of the Same Variety (No. 28, 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第28号 Registration & Filing 2023-07-31 2023-07-26
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on further strengthening the supervision of commissioned production by medical device registrants (draft for soliciting opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20230728 Manufacturing 2023-07-28 2023-07-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Clinical Evaluation, Registration and Review of Hip Joint Prostheses of the Same Variety (No. 27, 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第27号 Registration & Filing 2023-07-24 2023-07-20
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing the Catalogue of Medical Devices Exempted from Clinical Evaluation (No. 33 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2023年第33号 Clinical Evaluation 2023-07-24 2023-07-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Guidelines for registration and review of extracorporeal membrane oxygenation (ECMO) temperature control equipment
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第26号-f1 Registration & Filing 2023-07-20 2023-07-19
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
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