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Latest Regulations

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Notice on Adjusting the Business Scope of the Electronic Declaration Information System for Medical Device Registration (No. 7, 2024)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第7号 Registration & Filing 2024-02-05 2024-02-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Notice on Adjusting the Business Scope of the Electronic Declaration Information System for Medical Device Registration (No. 11, 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第11号 Registration & Filing 2023-04-19 2023-04-18
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice on Consultation on Digital Authentication (CA) Certificate of Medical Device Registration Electronic Declaration Information System
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221114-1 Registration & Filing 2022-11-14 2022-11-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notice on Issuing the Folder Structure of the Electronic Declaration Catalog for Medical Device Registration (No. 15, 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2021年第15号 Registration & Filing 2021-11-15 2022-01-01
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements Medical Device
Notice on the Trial Implementation of Electronic Signature for Registration and Application Materials of Imported Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200929-3 Registration & Filing 2020-09-29 2020-09-29
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notice on Matters Related to the Updating of Digital Authentication Certificates in the Electronic Declaration Information System for Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200518 Registration & Filing 2020-05-18 2020-05-18
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notice on the Related Submission and Prohibition of Repeated Submission of Electronic Declaration for Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2019年第15号 Registration & Filing 2019-10-14 2019-10-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice of the National Medical Products Administration on the Requirements for Electronic Declaration of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第41号 Registration & Filing 2019-07-10 2019-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Issuing the Folder Structure of the Electronic Declaration Catalogue (RPS ToC) for Medical Device Registration Electronic Declaration Information System
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2019年第5号 Registration & Filing 2019-06-06 2019-06-06
Status Issued By Level of Legal Effect Product Category Obsolete CMDE/Center for … Announcements IVD
Notice on Matters Related to the Business Processing of the Electronic Declaration Information System for Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2019年第4号 Registration & Filing 2019-06-06 2019-06-06
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
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