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Latest Regulations

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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 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
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
Guidelines for registration review of positron emission/X-ray computed tomography systems (digital technology specific)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第108号-f2 Registration & Filing 2022-01-19 2020-12-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guiding Principles for Registration Review of Pharmaceutical Device Combination Products with Medical Device Functions as the Main Function
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第3号-f1 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Combination Product
Guiding Principles for Registration and Review of Qualitative, Quantitative, and In Vitro Release Studies of Drugs in Pharmaceutical Device Combination Products with Medical Device Functions as the Main Function
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第3号-f2 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Combination Product
Guidelines for registration and review of disposable endoscopic injection needles
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第4号-f5 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Guiding principles for registration and review of artificial intraocular lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第4号-f6 Registration & Filing 2022-01-17 2022-01-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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