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Notice of the State Food and Drug Administration on Issuing Four Technical Review Guidelines for Medical Devices, including Fully Automatic Chemiluminescence Immunoassay Analyzers
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第93号-f4 Registration & Filing 2015-11-26 2015-11-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing Four Guiding Principles for Technical Review of Medical Devices, including Human Papillomavirus (HPV) Nucleic Acid Testing and Genotyping Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第93号-f3 Registration & Filing 2015-11-26 2015-11-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Food and Drug Administration on Issuing Four Technical Review Guidelines for Medical Devices, including Allergen Specific IgE Antibody Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第93号-f2 Registration & Filing 2015-11-26 2015-11-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Food and Drug Administration on Issuing Five Relevant Work Procedures, including the Procedure for Re applying for Medical Device Registration Certificates
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第91号 Registration & Filing 2015-11-23 2016-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Soliciting Opinions on the Guidelines for Writing Instructions for Passive Implantable Bone and Joint Products and Examples of Common Instructions for Passive Implantable Bone and Joint Products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20151120 Registration & Filing 2015-11-12 2015-11-12
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Interpretation of Medical Device Registration Management Regulations Part 4
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20151102 Registration & Filing 2015-11-02 2015-11-02
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Notice on Soliciting Opinions on the Guiding Principles for Registration and Application of Particle Beam Therapy Systems (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20151019-2 Registration & Filing 2015-10-19 2015-10-19
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Nucleic Acid Testing Reagents for Mycobacterium tuberculosis Composite Group
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第65号 Registration & Filing 2015-09-21 2015-09-21
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the General Office of the Food and Drug Administration on Enabling the Filing Subsystem of the Medical Device Registration Management Information System
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管函[2015]534号 Registration & Filing 2015-09-02 2015-09-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Opinions of the State Council on Reforming the Drug and Medical Device Evaluation and Approval System
Regulation No. Product LifeCycle Issued Date Implemented Date 国发[2015]44号 Registration & Filing 2015-08-18 2015-08-18
Status Issued By Level of Legal Effect Product Category Valid State Council … UNKNOWN UNKNOWN
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