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Guiding Principles for Registration and Review of Clinical Trials of Non original Accompanying Diagnostic Reagents for Antitumor Drugs
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第95号-f1 Registration & Filing 2021-12-01 2021-11-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Guiding principles for registration review of overseas clinical trial data using in vitro diagnostic reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第95号-f2 Registration & Filing 2021-12-01 2021-11-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Guidelines for Registration Review of Clinical Trial Data Submission Requirements for Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第91号-f1 Registration & Filing 2021-11-25 2021-11-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for Registration Review of Clinical Trial Data Submission Requirements for In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第91号-f2 Registration & Filing 2021-11-25 2021-11-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice on Public Solicitation of Comments on the Management Measures for Adverse Event Monitoring and Reevaluation of Medical Devices (Draft Amendment) by the National Medical Products Administration
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20211123 Usage 2021-11-23 2021-11-23
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD
Interpretation of the Guiding Principles for Registration and Review of Medical Device Animal Experiment Research
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20211122-1 Registration & Filing 2021-11-22 2021-11-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device
Notice on Issuing the Folder Structure of the Electronic Declaration Catalog for Medical Device Registration (No. 15, 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2021年第15号 Registration & Filing 2021-11-15 2022-01-01
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements Medical Device
Notice of the National Medical Products Administration on Issuing the Operating Norms for Registration and Approval of Domestic Class III and Imported Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监械注〔2021〕53号 Registration & Filing 2021-11-04 2021-11-02
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the National Medical Products Administration on Issuing the Operating Norms for Registration and Approval of Class II Medical Devices in China
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监械注〔2021〕54号 Registration & Filing 2021-11-04 2021-11-02
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Announcement of the National Medical Products Administration on Issuing the Classification Rules for In Vitro Diagnostic Reagents (No. 129 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第129号 Pre-Market 2021-10-29 2021-10-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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