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Latest Regulations

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Notice on Issuing Technical Guidelines for Electronic Submission of Medical Device Registration Applications
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第29号 Registration & Filing 2019-05-31 2019-05-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement on Implementing Electronic Declaration for Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第46号 Registration & Filing 2019-05-31 2019-05-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Adjusting the Attribute Definition of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第28号 Pre-Market 2019-05-31 2019-05-28
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Notice of the Comprehensive Department of the National Medical Products Administration on the Use of the Special Seal for Non tax Revenue Invoices of the National Medical Products Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综[2019]46号 Supervision & Inspection 2019-05-28 2019-05-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice on Issuing Guiding Principles for the Review of Three Registration Technologies, including Synthetic Resin Teeth
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第25号-f1 Registration & Filing 2019-05-22 2019-05-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing the Guiding Principles for the Review of Three Registration Technologies, including Intrauterine Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第25号-f2 Registration & Filing 2019-05-22 2019-05-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing Three Registration Technical Review Guidelines for Implantable Drug Delivery Devices and Other Items
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第25号-f3 Registration & Filing 2019-05-22 2019-05-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing Guiding Principles for Clinical Evaluation and Registration Technical Review of Centrifugal Blood Component Separation Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第24号 Clinical Evaluation 2019-05-15 2019-05-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing Technical Review Guidelines for Registration of Service Life of Active Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第23号 Registration & Filing 2019-05-14 2019-05-08
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Matters Related to the Application for Digital Authentication (CA) Certificates in the Electronic Declaration Information System for Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20190507 Registration & Filing 2019-05-07 2019-05-07
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
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