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Latest Regulations

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Regulations on the Procedures for Formulating Regulations by the State Administration for Market Regulation
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2019年第8号 Supervision & Inspection 2019-04-23 2019-06-01
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … Departmental Rules IVD
Notice on the release of two technical review guidelines, including animal experiments on intra-abdominal hernia repair patches
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第18号-f2 Registration & Filing 2019-04-19 2019-04-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the Equipment Review Center on External Consultation Work (No. 2 of 2019)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2019年第2号 Registration & Filing 2019-04-17 2019-04-16
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on soliciting public opinions on the draft outcome document of the "Clinical Evidence - Key Definitions and Concepts" coordination project
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20190412-4 Clinical Evaluation 2019-04-12 2019-04-12
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
Notice on Public Solicitation of Comments on the Draft Results Document of the "Clinical Trial" Coordination Project
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20190412-5 Clinical Evaluation 2019-04-12 2019-04-12
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
Notice on soliciting public opinions on the draft outcome document of the "Clinical Evaluation of Medical Devices" coordination project
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20190412-3 Clinical Evaluation 2019-04-12 2019-04-12
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
Notice on Issuing Guiding Principles for the Review of Three Registration Technologies, including Dental Vehicle Needles
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第16号-f1 Registration & Filing 2019-04-11 2019-04-03
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 Disposable Dispensing Syringes and Other Items
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第16号-f2 Registration & Filing 2019-04-11 2019-04-03
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 Disposable Skin Sutures and Other Items
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第16号-f3 Registration & Filing 2019-04-11 2019-04-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement on Adjusting the Approval Procedure for Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第26号 Clinical Evaluation 2019-04-01 2019-03-29
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
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