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Latest Regulations

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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 on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Disposable Non Absorbable Closure Clips (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20201102-1 Registration & Filing 2020-11-02 2020-11-02
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Soliciting Opinions on the Guiding Principles for the Safety and Effectiveness Evaluation Framework of Nanomaterials Used in Medical Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20201102-2 Registration & Filing 2020-11-02 2020-11-02
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Matters Related to Clinical Urgent Medical Device Registration and Application
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20201029 Registration & Filing 2020-10-29 2020-10-29
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device
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