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Latest Regulations

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Notice on Soliciting Opinions on the Guiding Principles for Technical Review of Endoscopic Camera System Registration (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20171129-1 Registration & Filing 2017-11-29 2017-11-29
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Announcement of the State Food and Drug Administration and the National Health and Family Planning Commission on Issuing the Conditions and Filing Management Measures for Clinical Trial Institutions of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局&卫计委公告2017年第145号 Clinical Evaluation 2017-11-24 2018-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Interpretation of the Regulations on the Conditions and Filing Management of Clinical Trial Institutions for Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20171124-1 Clinical Evaluation 2017-11-24 2017-11-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice of the General Office of the State Administration on Doing a Good Job in the Filing of Clinical Trial Institutions for Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]161号 Clinical Evaluation 2017-11-24 2017-11-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the State Administration on Issuing Guiding Principles for the Division of Medical Device Registration Units
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第187号 Pre-Market 2017-11-23 2017-11-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Decision of the State Food and Drug Administration on Amending Some Regulations
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2017年第37号 Distribution,Manufacturing 2017-11-21 2017-11-21
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Measures for the Administration of Internet Drug Information Services
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2004年第9号 Distribution 2017-11-21 2017-11-21
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Notice of the State Administration of Food and Drug Administration on soliciting public opinions on the revised draft of the Legislative Procedure Regulations of the State Food and Drug Administration
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20171117 Supervision & Inspection 2017-11-17 2017-11-17
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD
Announcement of the State Administration on the Clearing Results of Normative Documents Involved in the Reform of "streamlining administration, delegating powers, and improving services"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第136号 Product Type Testing 2017-11-17 2017-11-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Soliciting Opinions on the Guiding Principles for Technical Review of Dental Implants (Systems) Registration (Revised in 2017) (Draft for Soliciting Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20171116 Registration & Filing 2017-11-16 2017-11-16
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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