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Latest Regulations

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Notice on Issuing Operational Norms for Communication and Exchange of Technical Review and Evaluation of Innovative Priority Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20211202 Registration & Filing 2021-12-02 2021-12-01
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Notice on Matters Related to Payment of Fees for Medical Device Registration Application (No. 16, 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2021年第16号 Registration & Filing 2021-12-01 2021-12-01
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
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
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
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