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Notice on the Key Points for Technical Evaluation of Monkeypox Virus Nucleic Acid Testing Reagents (Trial) issued by the Equipment Review Center of the National Medical Products Administration (No. 31, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第31号 Registration & Filing 2022-07-15 2022-07-15
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
Notice on the Release of Clinical Evaluation Recommended Pathways for Related Products in Subcategories 01, 04, 07, 08, 09, 10, 19, and 21 of the Classification Catalogue of Medical Devices (No. 30, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第30号 Clinical Evaluation 2022-07-14 2022-07-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements Medical Device
Summary of Classification and Definition Results for Medical Devices in 2022
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20220713 Pre-Market 2022-07-13 2022-07-13
Status Issued By Level of Legal Effect Product Category Valid Center for … Work Documents Non-Medical Device
Notice on Issuing Technical Guidelines for Compliance with Basic Principles of Safety and Performance of Medical Devices by the Equipment Review Center of the National Medical Products Administration (No. 29, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第29号 Registration & Filing 2022-07-13 2022-07-12
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Announcement on the Migration and Renaming of the Human Genetic Resources Information Backup Platform
Regulation No. Product LifeCycle Issued Date Implemented Date MOST-20220711 Clinical Evaluation 2022-07-11 2022-07-11
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Announcements IVD
Summary of Attribute Definition Results for Pharmaceutical Device Combination Products from 2021 to 2022
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20220707 Pre-Market 2022-07-07 2022-07-07
Status Issued By Level of Legal Effect Product Category Valid Center for … Work Documents Combination Product
Notice on Publicly Soliciting Opinions on the Catalogue of Medical Devices Exempted from Clinical Evaluation and the Catalogue of In Vitro Diagnostic Reagents Exempted from Clinical Trials
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220705 Clinical Evaluation 2022-07-05 2022-07-05
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Implementation Plan for Supporting Hong Kong and Macao Drug Market Licensing Holders to Produce Drugs in 9 Mainland Cities of the Greater Bay Area and the Implementation Plan for Supporting Hong Kong and Macao Medical Device Registrants to Produce Medical Devices in 9 Mainland Cities of the Greater Bay Area
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综科外〔2022〕63号 Manufacturing 2022-06-29 2022-06-23
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 and Review of Clinical Trials of Original Research Accompanying Diagnostic Reagents Developed Simultaneously with Antitumor Drugs (No. 28, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第28号 Registration & Filing 2022-06-28 2022-06-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of Clinical Trials of PD-L1 Testing Reagents - Results Reproducibility Studies (No. 27, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第27号 Registration & Filing 2022-06-27 2022-06-27
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
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