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Latest Regulations

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Key points for evaluation of 3D printed intervertebral fusion cage technology
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第13号-f4 Registration & Filing 2022-03-31 2022-03-31
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing Guiding Principles for the Registration and Review of Intravascular Guidewires (No. 11, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第11号 Registration & Filing 2022-03-16 2022-03-15
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice on Issuing the Guiding Principles for Stability Research of Passive Implantable Medical Devices (Revised in 2022) by the Equipment Review Center of the National Medical Products Administration (No. 12 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第12号 Registration & Filing 2022-03-16 2022-03-15
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 Ophthalmic Laser Photocoagulation Machines (No. 6, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第6号 Registration & Filing 2022-03-09 2022-03-04
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 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
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