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Latest Regulations

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Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Facial Implants for Plastic Surgery
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第36号-f4 Registration & Filing 2020-06-05 2020-06-03
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 Five Products, including Total Knee Joint Prosthesis Systems
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第36号-f5 Registration & Filing 2020-06-05 2020-06-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Guiding Principles for Independent Software Field Inspection of Medical Device Production Quality Management Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管[2020]57号 Manufacturing 2020-06-04 2020-05-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Human Factors Design of Medical Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200521-1 Registration & Filing 2020-05-21 2020-05-21
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 Evaluation Guidelines for Raw Material Changes in Passive Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第33号 Registration & Filing 2020-05-19 2020-05-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice on Matters Related to the Updating of Digital Authentication Certificates in the Electronic Declaration Information System for Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200518 Registration & Filing 2020-05-18 2020-05-18
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Technical Review of Registration of Dengue Virus Nucleic Acid Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第32号 Registration & Filing 2020-05-14 2020-05-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of 7 Registration Technologies, including Vertebroplasty Balloon Dilation Catheters
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第31号-f1 Registration & Filing 2020-05-09 2020-04-30
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 Seven Registration Technologies, including Acrylic Resin Bone Cement for Artificial Joint Replacement Surgery
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第31号-f2 Registration & Filing 2020-05-09 2020-04-30
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 7 Registration Technologies, including Metal Intramedullary Nail System Products
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第31号-f3 Registration & Filing 2020-05-09 2020-04-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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