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Latest Regulations

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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 Two Registration Technical Review Guiding Principles, including the Clinical Evaluation Technical Review Guidelines for the Same Variety of Imaging Ultrasound Diagnostic Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第2号 Clinical Evaluation 2021-01-18 2021-01-15
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 Two Registration Technical Review Guidelines for Clinical Evaluation of X-ray Computed Tomography Equipment of the Same Variety and Other Two Registration Technical Review Guidelines
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第2号-1 Clinical Evaluation 2021-01-18 2021-01-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Forwarding Notice on Soliciting Opinions on the Recommended National Standard (Draft for Comments) for the Application of Medical Device Quality Management System in Regulations
Regulation No. Product LifeCycle Issued Date Implemented Date 国质管标〔2021〕3号 Product Type Testing 2021-01-11 2022-01-11
Status Issued By Level of Legal Effect Product Category Draft Center for … Normative Documents IVD
Announcement of the National Medical Products Administration on Further Standardizing the Instructions for Medical Ultrasound Couplants and Other Related Content
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第143号 Pre-Market 2021-01-05 2020-12-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement of the National Medical Products Administration on Adjusting Part of the Content of the Classification Catalogue of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第147号 Pre-Market 2020-12-31 2020-12-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement of the National Medical Products Administration on Adjusting Part of the Content of the Classification Catalogue of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第147号 Pre-Market 2020-12-31 2020-12-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on further strengthening the standardization of medical devices (draft for soliciting opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20201231 Product Type Testing 2020-12-31 2020-12-31
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD
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