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Notice of the National Medical Products Administration on Issuing the Guiding Principles for Registration Review of Neuro and Cardiovascular Surgical Instruments - Knives, Scissors, and Needles (No. 92 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第92号 Registration & Filing 2021-12-01 2021-11-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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
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
Guiding Principles for Registration and Review of Traditional Chinese Medicine Moxibustion Equipment (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20211022-3-f29 Registration & Filing 2021-10-22 2021-10-22
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for bacterial endotoxin limits and detection of disposable intraocular ophthalmic instruments (draft for soliciting opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20211022-3-f22 Registration & Filing 2021-10-22 2021-10-22
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Medical Device Animal Experiment Research Part 1: Decision Principles (Revised in 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告第75号-f1 Registration & Filing 2021-09-27 2021-09-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guiding Principles for Registration and Review of Medical Device Animal Experiment Research Part 2: Experimental Design and Implementation Quality Assurance
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告第75号-f2 Registration & Filing 2021-09-27 2021-09-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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