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Latest Regulations

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Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Four Registration Technologies, including Aspartate Aminotransferase Assay Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第74号-f1 Registration & Filing 2019-10-29 2019-10-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Four Registration Technologies, including Total Cholesterol Determination Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第74号-f2 Registration & Filing 2019-10-29 2019-10-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Four Registration Technologies, including Uric Acid Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第74号-f3 Registration & Filing 2019-10-29 2019-10-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing Guiding Principles for the Review of Four Registration Technologies, including Urea Determination Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第74号-f4 Registration & Filing 2019-10-29 2019-10-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice on Public Solicitation of Opinions on 27 Second Class Guiding Principles, including the Technical Guidelines for Registration of Instructions and Confirmation Methods for Reprocessing Reusable Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191018-4 Registration & Filing 2019-10-18 2019-10-17
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on 27 Second Class Guiding Principles, including the Technical Guidelines for Registration of Pediatric Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191018-7 Registration & Filing 2019-10-18 2019-10-17
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on 27 Second Class Guiding Principles, including the Technical Guidelines for Replacing Sterile Testing Registration with Container and Sealing System Integrity Testing in the Validation of Shelf Life of Sterile Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191018-8 Registration & Filing 2019-10-18 2019-10-17
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on 27 Second Class Guiding Principles, including the Guiding Principles for Technical Review of Registration of Dental Film Orthodontics Products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191018-21 Registration & Filing 2019-10-18 2019-10-17
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Supplementary Notice on Providing Pre examination Services for Technical Evaluation and Correction of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191016-1 Registration & Filing 2019-10-16 2019-11-01
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Registration of Dental Implant Base Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191015-1 Registration & Filing 2019-10-15 2019-10-15
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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