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Latest Regulations

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Notice of the National Medical Products Administration on Issuing Six Guiding Principles for the Evaluation of Fatigue Performance of Biotype Femoral Stem and Stem
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第62号-f3 Registration & Filing 2020-09-24 2020-09-17
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 Six Guiding Principles, including the Validation of Virus Inactivation Process for Allogeneic Implantable Medical Devices (Revised in 2020)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第62号-f4 Registration & Filing 2020-09-24 2020-09-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice from the National Medical Products Administration on Issuing Six Guiding Principles for 3D Printing of Patient Matching Mandibular Prostheses
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第62号-f5 Registration & Filing 2020-09-24 2020-09-17
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 Six Guiding Principles for Personalized Matching of Bone Implants and Tools, including Medical and Industrial Mutual Quality Control
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第62号-f6 Registration & Filing 2020-09-24 2020-09-17
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 Catalogue of Class III Medical Devices Subject to Clinical Trial Approval (Revised in 2020)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第61号 Clinical Evaluation 2020-09-18 2020-09-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Revision Explanation of the Catalogue of Class III Medical Devices Subject to Clinical Trial Approval (2020 Revision)
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20200918-1 Clinical Evaluation 2020-09-18 2020-09-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device
Establish a project team evaluation system for high-quality, efficient, and scientific evaluation
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200828-3 Registration & Filing 2020-08-28 2020-08-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Cryptococcal Antigen Detection Reagent Registration (Draft for Soliciting Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200821-3 Registration & Filing 2020-08-21 2020-08-21
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Clinical Trials of Accompanying Diagnostic Reagents of Marketed Antitumor Drugs (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200813-2 Clinical Evaluation 2020-08-13 2020-08-13
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Notice on Soliciting Opinions on the New and Revised Catalogue of Medical Devices Exempted from Clinical Trials in 2020 (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200729-1 Clinical Evaluation 2020-07-29 2020-07-29
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
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