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Draft Quality Technical Specifications for Clinical Trials of Medical Devices (for Comments) and Compilation Instructions
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230905-1 Clinical Evaluation 2023-09-05 2023-09-04
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
Quality Technical Specifications for Clinical Trials of In Vitro Diagnostic Reagents (Draft for Comments) and Compilation Instructions
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230905-2 Clinical Evaluation 2023-09-05 2023-09-04
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Absorbable Internal Fixation Implants Part 1: Synthetic Polymer Materials (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230904 Registration & Filing 2023-09-04 2023-09-04
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 Electronic Endoscopes of the Same Variety (No. 35 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第35号 Registration & Filing 2023-08-30 2023-08-29
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, Registration and Review of Soft Contact Lenses (No. 33 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第33号 Registration & Filing 2023-08-23 2023-08-23
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Announcement of the National Medical Products Administration on the Release of Four Informatization Standards, including the Basic Dataset for Medical Device Registration and Filing Management (No. 103 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2023年第103号 Registration & Filing 2023-08-18 2023-08-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Announcement of the National Medical Products Administration on Adjusting Part of the Content of the Classification Catalogue of Medical Devices (No. 101 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2023年第101号 Pre-Market 2023-08-17 2023-08-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Rehabilitation Digital Therapy Software Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20230816 Registration & Filing 2023-08-16 2023-08-16
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines Medical Device
Notice on Issuing the Guiding Principles for Clinical Evaluation, Registration and Review of Same Variety Dental Implant Systems by the Equipment Review Center of the National Medical Products Administration (No. 32 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第32号 Registration & Filing 2023-08-14 2023-08-14
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, Registration and Review of Hemodialysis Concentrates (No. 29, 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第29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
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