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Letter from the Equipment Department of the State Food and Drug Administration on soliciting opinions on the temporary regulations for the registration and management of in vitro diagnostic reagents packaging
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械函[2012]83号 Manufacturing 2012-11-02 2012-11-02
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Normative Documents IVD
Notice of the State Food and Drug Administration on Issuing the Rules for the Discretionary Application of Administrative Penalties on Drugs and Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国食药监法[2012]306号 Supervision & Inspection 2012-11-02 2013-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including Medical Molecular Sieve Oxygen Production Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2012]210号-f9 Registration & Filing 2012-05-10 2012-05-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including Surgical Power Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2012]210号-f8 Registration & Filing 2012-05-10 2012-05-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing Technical Review Guidelines for the Registration of 12 Medical Device Products, including Respiratory Pipelines for Anesthesia and Respiratory Machines
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械函[2012]210号-f11 Registration & Filing 2012-05-10 2012-05-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Soliciting Opinions on Three Guiding Principles, including the Technical Guidelines for Registration and Application of Virus-specific IgM Antibody Qualitative Detection Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20120428-2-f1 Registration & Filing 2012-04-28 2012-04-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Explanation on Basic Requirements for Medical Device Software Registration and Application
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20120428-1 Registration & Filing 2012-04-28 2012-04-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device
Notes on registration and application of respiratory intubation products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20120316 Registration & Filing 2012-03-16 2012-03-16
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device
Notice on the Management of Decorative Colored Flat Light Contact Lenses in accordance with Medical Device Management
Regulation No. Product LifeCycle Issued Date Implemented Date 国食药监械[2012]66号 Pre-Market 2012-02-27 2012-02-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Announcement on the Management of Decorative Colored Flat Light Contact Lenses According to Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2012年第7号 Pre-Market 2012-02-27 2012-02-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
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