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Latest Regulations

1220  Results

Guidelines for Technical Review of Registration of Rotavirus Antigen Testing Agents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第24号-f3 Registration & Filing 2021-04-15 2021-04-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Guidelines for Technical Review of Registration of Group B Streptococcus Nucleic Acid Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第24号-f4 Registration & Filing 2021-04-15 2021-04-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Guidelines for Technical Review of Registration of Human Parvovirus B19IgM/IgG Antibody Detection Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第24号-f5 Registration & Filing 2021-04-15 2021-04-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Regulations on the Supervision and Administration of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第739号 Usage,Supervision & Inspection,Distribution,Registration & Filing,Pre-Market,Manufacturing,Clinical Evaluation,Product Type Testing 2021-03-18 2021-06-01
Status Issued By Level of Legal Effect Product Category Valid State Council … UNKNOWN UNKNOWN
Guidelines for Technical Review of Low Temperature Gas Sterilizer Registration (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210317-f4 Registration & Filing 2021-03-17 2021-03-17
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Technical Review of Registration of X-ray Imaging Devices for Pediatric Applications (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210317-f8 Registration & Filing 2021-03-17 2021-03-17
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Technical Review of Registration of Anti Mueller's Hormone Assay Reagents (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210317-f9 Registration & Filing 2021-03-17 2021-03-17
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Notice on Receiving Paper Materials for Self Withdrawal of Medical Device Registration Application Projects (No. 4, 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2021年第4号 Registration & Filing 2021-03-17 2021-03-17
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Announcement of the National Medical Products Administration on the Registration of Main Documents for Medical Devices (No. 36 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE公告2021年第36号 Registration & Filing 2021-03-12 2021-03-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
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
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