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Latest Regulations

165  Results

Notice of the General Office of the Ministry of Science and Technology on the Opening and Operation of the Online Application System for the Collection, Collection, Trading, Export, and Exit Approval of Human Genetic Resources
Regulation No. Product LifeCycle Issued Date Implemented Date 国科办函社[2016]758号 Clinical Evaluation 2016-10-24 2016-10-14
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Normative Documents IVD
Notice of the State Administration on Carrying out Supervision and Sampling of Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第98号（附件1，2） Clinical Evaluation 2016-06-08 2016-06-08
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Technical guidelines for clinical evaluation of pulse oximeter equipment
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20160405 Clinical Evaluation 2016-04-05 2016-04-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Quality Management Specification for Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局&国家卫计委令2016年第25号 Clinical Evaluation 2016-03-23 2016-06-01
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Interpretation of the Quality Management Standards for Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20160323 Clinical Evaluation 2016-03-23 2016-03-23
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents Medical Device
Notice of the State Administration on Issuing Six Documents, including the Model Application and Approval Form for Ethical Review of Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第58号 Clinical Evaluation 2016-03-23 2016-03-15
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements Medical Device
Announcement on Matters Related to the Seals of Clinical Trial Institutions for In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CCRCFDA公告2015年第154号 Clinical Evaluation 2015-09-09 2015-09-09
Status Issued By Level of Legal Effect Product Category Valid Administrative Acceptance … Announcements IVD
Announcement of the State Food and Drug Administration on Matters Related to Clinical Trial Filing of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第87号 Clinical Evaluation 2015-07-03 2015-07-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Key points for clinical trial evaluation of fully degradable coronary drug-eluting stents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20150423-2 Clinical Evaluation 2015-04-23 2015-04-23
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Combination Product
Key points for clinical trial evaluation of aortic covered stent system
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20150423-1 Clinical Evaluation 2015-04-23 2015-04-23
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device
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