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Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Network Security Registration and Review of Medical Devices (Revised in 2022) (No. 7 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第7号 Registration & Filing 2022-03-09 2022-03-07
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice on Issuing Guiding Principles for Registration Review of Artificial Intelligence Medical Devices by the Equipment Review Center of the National Medical Products Administration (No. 8, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第8号 Registration & Filing 2022-03-09 2022-03-07
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice on Issuing the Guiding Principles for Medical Device Software Registration Review (Revised in 2022) by the Equipment Review Center of the National Medical Products Administration (No. 9 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第9号 Registration & Filing 2022-03-09 2022-03-07
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of Laser Selected Melted Metal Materials for Additive Manufacturing and Oral Repair (No. 5, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第5号 Registration & Filing 2022-03-03 2022-03-03
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for the Uniformity of Physical and Chemical Properties of Metal Implants in Additive Manufacturing (No. 4, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第4号 Registration & Filing 2022-03-01 2022-02-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration Review of Additive Manufacturing Polyether Ether Ketone Implants (No. 3, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第3号 Registration & Filing 2022-02-28 2022-02-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Work Procedures for Checking the Registration Quality Management System of Class III Medical Devices in China
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注〔2022〕13号 Registration & Filing 2022-02-11 2022-02-09
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 Guiding Principles for Writing Technical Requirements for Medical Device Products (No. 8, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第8号 Registration & Filing 2022-02-09 2022-02-08
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Announcement of the National Medical Products Administration on Issuing Supplementary Testing Methods for Identification and Content Determination of 17 Chemical Drugs in Adhesive Medical Devices (No. 12, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第12号 Product Type Testing 2022-01-26 2022-01-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Guiding Principles for Registration Review of Biosafety Cabinets
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第108号-f1 Registration & Filing 2022-01-19 2021-12-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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