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Latest Regulations

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Notice on Publicly Soliciting Opinions on the Guiding Principles for Registration and Review of CT Imaging Assisted Detection Software for Pulmonary Nodules
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220112 Registration & Filing 2022-01-12 2022-01-10
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the National Medical Products Administration on the Implementation of the Catalogue of Class I Medical Device Products (No. 107 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第107号 Pre-Market 2021-12-31 2021-12-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Revision Explanation of the Catalogue of Class I Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20211231-2 Pre-Market 2021-12-31 2021-12-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device
Announcement of the National Medical Products Administration on Issuing the Catalogue of Class I Medical Device Products (No. 158 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第158号 Pre-Market 2021-12-31 2022-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement of the National Medical Products Administration on Issuing the Emergency Approval Procedure for Medical Devices (No. 157 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第157号 Registration & Filing 2021-12-30 2021-12-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Guidelines for registration review of fluorescence immunoassay analyzers
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第104号-f1 Registration & Filing 2021-12-28 2021-12-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guiding principles for registration and review of net atomizers
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第104号-f2 Registration & Filing 2021-12-28 2021-12-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for registration and review of medical diagnostic X-ray equipment containing pediatric applications
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第104号-f3 Registration & Filing 2021-12-28 2021-12-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for registration and review of ultrasound transcranial Doppler blood flow analyzers
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第104号-f4 Registration & Filing 2021-12-28 2021-12-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guidelines for registration and review of anti Mullerian hormone assay reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第104号-f14 Registration & Filing 2021-12-28 2021-12-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
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