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Latest Regulations

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Guidelines for Technical Review of Registration of Anti Mueller's Hormone Assay Reagents (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210317-f9 Registration & Filing 2021-03-17 2021-03-17
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Technical Review of Three Registration Technologies, including IgM/IgG Antibody Testing Reagents for Mycoplasma Pneumonia
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第4号 Registration & Filing 2021-01-19 2021-01-18
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 Three Registration Technologies, including Cryptococcus capsular polysaccharide antigen detection reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第4号-1 Registration & Filing 2021-01-19 2021-01-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing Three Registration Technical Review Guidelines for Genetic Deafness Related Gene Mutation Detection Reagents and Other Matters
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第4号-2 Registration & Filing 2021-01-19 2021-01-18
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 Technical Review of Fundus Camera Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第87号-1 Registration & Filing 2020-12-21 2020-12-17
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 the Guiding Principles for Technical Review of Electronic Upper Gastrointestinal Endoscopy Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第87号 Registration & Filing 2020-12-21 2020-12-17
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 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
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