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Latest Regulations

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Notice of the State Food and Drug Administration on Issuing Three Technical Review Guidelines for Medical Devices, including Imaging Ultrasound Diagnostic Equipment (Class III)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第112号-f3 Registration & Filing 2016-01-13 2015-12-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Interpretation of Medical Device Registration Management Regulations Part 6
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20160107 Pre-Market 2016-01-07 2016-01-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device
Announcement on Carrying out Designated Inspection Work for Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date CCRCFDA公告2016年第164号 Product Type Testing 2015-12-31 2016-01-01
Status Issued By Level of Legal Effect Product Category Obsolete Administrative Acceptance … Announcements IVD
Notice of the State Administration for Food and Drug Administration, the Ministry of Public Security, the Supreme People's Court, the Supreme People's Procuratorate, and the Food Safety Office of the State Council on Issuing the Measures for the Connection between Food and Drug Administrative Law Enforcement and Criminal Justice
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监稽[2015]271号 Supervision & Inspection 2015-12-22 2015-12-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Naming rules for universal names of medical devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2015年第19号 Pre-Market 2015-12-21 2016-04-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Notice of the General Office of the State Council on the Implementation of the Medical Device Registration Management Information System for Acceptance, Certification, Technical Evaluation, and Administrative Approval Subsystems
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管函[2015]804号 Registration & Filing 2015-12-15 2015-12-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the State Food and Drug Administration on Issuing Management Regulations for Designated Inspection of Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第94号 Product Type Testing 2015-11-27 2015-11-27
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements IVD
Notice of the State Food and Drug Administration on Issuing Four Guiding Principles for Technical Review of Medical Devices, including Hepatitis C Virus Nucleic Acid Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第93号-f1 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 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
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