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Interpretation of the Announcement on Registration Matters of Medical Device Master Documents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210312 Registration & Filing 2021-03-12 2021-03-12
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notice on Matters Related to the Registration of Medical Device Master Documents (No. 2, 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2021年第2号 Registration & Filing 2021-03-12 2021-03-12
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the English Names of the Second Batch of Key Laboratories
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综科外函〔2021〕115号 Clinical Evaluation 2021-03-02 2021-02-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the National Medical Products Administration on the Recognition of the Second Batch of Key Laboratories
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监科外函〔2021〕17号 Clinical Evaluation 2021-02-09 2021-02-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Management Measures for Clinical Use of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国家卫生健康委员会令第8号 Usage 2021-02-04 2021-03-01
Status Issued By Level of Legal Effect Product Category Valid National Heath … UNKNOWN UNKNOWN
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Technical Review of Clinical Evaluation of Medical Magnetic Resonance Imaging Systems of the Same Variety (Revised in 2020)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第12号 Clinical Evaluation 2021-02-01 2021-01-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing the Catalogue of Medical Devices Exempted from Clinical Trials (Second Batch Revision)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第3号 Clinical Evaluation 2021-01-19 2021-01-14
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Technical Review of Three Registration Technologies, including IgM/IgG Antibody Testing Reagents for Mycoplasma Pneumonia
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第4号 Registration & Filing 2021-01-19 2021-01-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Three Registration Technologies, including Cryptococcus capsular polysaccharide antigen detection reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第4号-1 Registration & Filing 2021-01-19 2021-01-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing Three Registration Technical Review Guidelines for Genetic Deafness Related Gene Mutation Detection Reagents and Other Matters
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第4号-2 Registration & Filing 2021-01-19 2021-01-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
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