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National Standard Management Measures
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2022年第59号 Product Type Testing 2022-09-09 2023-03-01
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … Departmental Rules IVD
Notice of the National Medical Products Administration on the Use of Electronic Payment Certificates for Registration Fees of Drugs and Medical Devices (No. 37 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第37号 Registration & Filing 2022-09-02 2022-08-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Reply from the Comprehensive Department of the National Medical Products Administration on Whether Automobile Sales Enterprises Operating Ambulances Containing Medical Device Products Should Apply for Business Qualifications
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管函〔2022〕505号 Distribution 2022-09-02 2022-08-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice of the National Medical Products Administration on Issuing Documents such as "Requirements for Examination of Registration Projects for Medical Device Products" (No. 40 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第40号 Registration & Filing 2022-08-31 2022-08-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of Quantitative Testing in Vitro Diagnostic Reagent Analysis Performance Evaluation (No. 32 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第32号 Registration & Filing 2022-08-26 2022-08-26
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Circular of the Center for Organic Examination of the State Food and Drug Administration on Issuing the Key Points for Technical Review of the novel coronavirus Nucleic Acid Sampling Equipment in the Oropharynx (Trial) (No. 33 in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第33号 Registration & Filing 2022-08-26 2022-08-26
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Remote Monitoring Systems (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220822 Registration & Filing 2022-08-22 2022-08-22
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Announcement of the National Medical Products Administration on Matters Related to the Filing of Class I Medical Devices (No. 62 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第62号 Registration & Filing 2022-08-11 2022-08-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Revision Explanation of the Announcement on Matters Related to the Filing of Class I Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20220811 Registration & Filing 2022-08-11 2022-08-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice on Activating the Second Page of the New Inspection Report of the China Inspection and Quarantine Institute
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20220727 Product Type Testing 2022-07-27 2022-07-27
Status Issued By Level of Legal Effect Product Category Valid National Health … Work Documents IVD
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