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Latest Regulations

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Notice on Matters Related to Consultation on Technical Evaluation and Correction of Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2020年第24号 Registration & Filing 2020-12-10 2020-12-10
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice of the National Medical Products Administration on Issuing Seven Guiding Principles for Registration Technical Review of Household In Vitro Diagnostic Medical Devices, including the Guiding Principles for Registration Technical Review
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第80号-1 Registration & Filing 2020-12-09 2020-12-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing Seven Guiding Principles for Registration Technology Review of Specific Protein Immunoassay Analyzers
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第80号-2 Registration & Filing 2020-12-09 2020-12-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Seven Guiding Principles for Registration Technical Review of Prolactin Testing Reagents, including the Guiding Principles for Registration Technical Review
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第80号-3 Registration & Filing 2020-12-09 2020-12-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice from the National Medical Products Administration on Issuing Seven Guiding Principles for Registration Technical Review of Total Triiodothyronine Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第80号-4 Registration & Filing 2020-12-09 2020-12-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice from the National Medical Products Administration on Issuing Seven Guiding Principles for Registration Technical Review of 25-HydroxyVitamin D Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第80号-5 Registration & Filing 2020-12-09 2020-12-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing Seven Guiding Principles for Registration Technical Review of Serum Amyloid Protein A Testing Reagents, including the Guiding Principles for Registration Technical Review
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第80号-6 Registration & Filing 2020-12-09 2020-12-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing Seven Guiding Principles for Registration Technical Review of Rheumatoid Factor Testing Reagents, including the Guiding Principles for Registration Technical Review
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第80号-7 Registration & Filing 2020-12-09 2020-12-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Clarifying Matters Related to the Labeling of Qualification Identification Marks in the Medical Device Inspection Work Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综科外函〔2020〕746号 Product Type Testing 2020-12-08 2020-12-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the National Medical Products Administration on Issuing Five Guiding Principles, including the Naming Guidelines for Universal Names of Orthopedic Surgical Instruments
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第79号-1 Pre-Market 2020-12-07 2020-11-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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