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Latest Regulations

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Notice on Public Solicitation of Opinions on the Guiding Principles for the Establishment and Characterization of Evaluation Methods for Unknown Leachable Substances in Medical Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200624-2 Registration & Filing 2020-06-24 2020-06-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of 8 Registration Technologies, including Heat and Humidity Exchangers
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第39号-f1 Registration & Filing 2020-06-17 2020-06-09
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 the Guiding Principles for the Review of 8 Registration Technologies, including Low Frequency Electrotherapy Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第39号-f2 Registration & Filing 2020-06-17 2020-06-09
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 the Guiding Principles for the Review of 8 Registration Technologies, including Electric Pressure Hemostatic Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第39号-f3 Registration & Filing 2020-06-17 2020-06-09
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 the Guiding Principles for Technical Review of Registration of 8 Products, including Pulmonary Ventilation Function Testing
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第39号-f4 Registration & Filing 2020-06-17 2020-06-09
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 the Guiding Principles for the Review of 8 Registration Technologies, including Medical Carbon Dioxide Incubators
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第39号-f5 Registration & Filing 2020-06-17 2020-06-09
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 the Guiding Principles for the Review of 8 Registration Technologies, including Shock Wave Therapy Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第39号-f6 Registration & Filing 2020-06-17 2020-06-09
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 the Guiding Principles for Technical Review of Registration of 8 Products, including Hot compress Stickers (Bags)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第39号-f7 Registration & Filing 2020-06-17 2020-06-09
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 the Guiding Principles for the Examination of 8 Registration Technologies, including Audiometers
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第39号-f8 Registration & Filing 2020-06-17 2020-06-09
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on the Exit Registration Procedure and Subsequent Handling Methods for Imported Medical Devices Applying for Product Registration in Class II and Confirmed as Class III through Technical Evaluation
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200605-2 Registration & Filing 2020-06-05 2020-06-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
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