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Latest Regulations

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Measures for the Supervision and Administration of Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2022年第53号 Manufacturing 2022-03-22 2022-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Measures for the Supervision and Administration of Medical Device Operation
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2022年第54号 Distribution 2022-03-22 2022-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
The General Office of the Central Committee of the Communist Party of China and the General Office of the State Council have issued the "Opinions on Strengthening the Governance of Science and Technology Ethics"
Regulation No. Product LifeCycle Issued Date Implemented Date 220509-SC-20220320 Clinical Evaluation 2022-03-20 2022-03-20
Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents IVD
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing Guiding Principles for the Registration and Review of Intravascular Guidewires (No. 11, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第11号 Registration & Filing 2022-03-16 2022-03-15
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice on Issuing the Guiding Principles for Stability Research of Passive Implantable Medical Devices (Revised in 2022) by the Equipment Review Center of the National Medical Products Administration (No. 12 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第12号 Registration & Filing 2022-03-16 2022-03-15
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Technical Review Points for Clinical Trial Data of Human SDC2 Gene Methylation Detection Reagent
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第10号-f1 Clinical Evaluation 2022-03-14 2022-03-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
Technical evaluation points for clinical trial data of abnormal prothrombin assay reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第10号-f2 Clinical Evaluation 2022-03-14 2022-03-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
Key points for technical evaluation of clinical trial data of Helicobacter pylori 23S rRNA gene mutation detection reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第10号-f3 Clinical Evaluation 2022-03-14 2022-03-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
Key points for technical review of registration of novel coronavirus antigen detection reagent (trial)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第10号-f4 Clinical Evaluation 2022-03-14 2022-03-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration Review of Ophthalmic Laser Photocoagulation Machines (No. 6, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第6号 Registration & Filing 2022-03-09 2022-03-04
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
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