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Latest Regulations

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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 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
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
Notice on Issuing Four Guiding Principles for Clinical Evaluation of Oral and Maxillofacial Cone Beam Computed Tomography Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第10号-f4 Clinical Evaluation 2019-03-26 2019-02-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on the release of three clinical trial guidelines for ophthalmic femtosecond laser therapy machines used for corneal flap preparation
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第13号-f3 Clinical Evaluation 2019-03-20 2019-03-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on the release of three clinical trial guidelines, including sodium hyaluronate facial injection filling materials
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第13号-f2 Clinical Evaluation 2019-03-20 2019-03-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on the release of three clinical trial guidelines, including artificial lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第13号-f1 Clinical Evaluation 2019-03-20 2019-03-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing Three Clinical Trial Guidelines for Catheter Implantable Artificial Aortic Valve and Other Applications
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第8号-f3 Clinical Evaluation 2019-03-01 2019-02-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on the release of three clinical trial guidelines, including bioabsorbable coronary artery drug-eluting stents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第8号-f2 Clinical Evaluation 2019-03-01 2019-02-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Combination Product
Notice on the release of three clinical trial guidelines, including the aortic covered stent system
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第8号-f1 Clinical Evaluation 2019-03-01 2019-02-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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