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Latest Regulations

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Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Inspection Points and Determination Principles for Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注[2018]45号 Clinical Evaluation 2018-11-28 2018-11-19
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Comparison of Same Variety of In Vitro Diagnostic Reagents Exempted from Clinical Trials (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20181122-2 Clinical Evaluation 2018-11-22 2018-11-22
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Notice of the National Medical Products Administration on Publishing the Newly Revised Catalogue of Medical Devices Exempted from Clinical Trials
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第94号 Clinical Evaluation 2018-09-30 2018-09-28
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Notice on soliciting opinions on the draft guidelines for animal experiments and clinical evaluation of implantable sacral nerve stimulation systems
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20180927-3 Clinical Evaluation 2018-09-27 2018-09-27
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 Two Clinical Trial Guiding Principles for Corneal Sculpture, including Hard Breathable Contact Lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第51号-f1 Clinical Evaluation 2018-07-05 2018-06-29
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 Two Guiding Principles for Clinical Trials, including Soft Contact Lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第51号-f2 Clinical Evaluation 2018-07-05 2018-06-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of Shanghai Food and Drug Administration on the Implementation of the "Legal Person One Certificate Pass" Signature for Clinical Trial Filing of Medical Devices in this City
Regulation No. Product LifeCycle Issued Date Implemented Date 沪食药监械注[2018]116号 Clinical Evaluation 2018-06-15 2018-07-01
Status Issued By Level of Legal Effect Product Category Valid UNKNOWN Normative Documents IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Writing Approval and Application Materials for Clinical Trials of Passive Implantable Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第40号 Clinical Evaluation 2018-06-11 2018-06-04
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 Clinical Trials of Coronary Artery Drug eluting Stents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第21号-f2 Clinical Evaluation 2018-05-11 2018-05-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Combination Product
Notice of the National Medical Products Administration on Issuing the Preclinical Research Guidelines for Coronary Artery Drug eluting Stents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第21号-f1 Clinical Evaluation 2018-05-11 2018-05-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Combination Product
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