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Notice on Public Solicitation of Opinions on the Guiding Principles for Biological Evaluation of Medical Devices Part 1: General Provisions (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20181113 Registration & Filing 2018-11-13 2018-11-12
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Issuing Guiding Principles for the Review of Three Registration Technologies, including Umbilical Cord Protection
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第116号-f1 Registration & Filing 2018-11-13 2018-11-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement on approving the release of 14 medical device industry standards and 1 amendment form, including YY0060-2018 "Hot compress patches (bags)"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第87号 Product Type Testing 2018-11-12 2018-11-07
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice of the Comprehensive Department of the National Medical Products Administration on the Use of the Administrative Reconsideration Special Seal of the National Medical Products Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综法[2018]36号 Supervision & Inspection 2018-11-07 2018-11-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Announcement of the National Medical Products Administration on Issuing the Special Review Procedure for Innovative Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第83号 Pre-Market 2018-11-05 2018-12-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Interpretation of the Special Review Procedure for Innovative Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20181105 Pre-Market 2018-11-05 2018-11-05
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Review of Reusable Medical Device Reprocessing Verification Methods and Identification Registration Technology (Part 1) (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20181101 Registration & Filing 2018-11-01 2018-11-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the National Medical Products Administration on Handling Matters for Medical Device Operating Enterprises to Set up Warehouse Across Administrative Regions
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第108号 Supervision & Inspection,Distribution 2018-10-31 2019-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the National Medical Products Administration on Issuing Three Registration Technical Review Guidelines for Orthopedic External Fixation Stents and Other Items
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第107号-f1 Registration & Filing 2018-10-30 2018-10-25
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 Three Guiding Principles for Registration Technical Review of Disposable Medical Laryngeal Masks and Other Items
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第107号-f2 Registration & Filing 2018-10-30 2018-10-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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