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Interpretation of Medical Device Registration Management Regulations III (Explanation on the Revision of the Classification Rules for Medical Devices)
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150716 Pre-Market 2015-07-16 2016-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Combination Product
Notice of the General Office of the Food and Drug Administration on the Classification and Definition of 22 Products, including Thermostatic Nucleic Acid Amplification Detectors
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2015]75号 Pre-Market 2015-06-11 2015-06-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the State Administration for Food and Drug Administration on the Classification and Definition of 172 Products, including Artificial Vascular Rings
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2015]69号 Pre-Market 2015-05-18 2015-05-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice of the General Office of the Food and Drug Administration on the Classification and Definition of 153 Products, including Breast Photography Stereoscopic Positioning Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2015]49号 Pre-Market 2015-03-31 2015-03-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the Food and Drug Administration on the Classification and Definition of 61 Products, including Automatic Control and Positioning Devices for Endoscopes Used in Laparoscopic Surgery
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2014]198号 Pre-Market 2014-11-24 2014-11-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice of the General Office of the Food and Drug Administration on the classification and definition of 34 products including cross-linked and aminated polyvinyl alcohol foam plugging lung volume reduction system
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2014]177号 Pre-Market 2014-09-22 2014-09-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice of the General Office of the State Administration for Food and Drug Administration on the Classification and Definition of 30 Products, including Electronic Uterine Observation Mirrors
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2014]149号 Pre-Market 2014-08-01 2014-08-01
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 the Catalogue of Class I Medical Device Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第8号 Pre-Market 2014-05-30 2014-05-30
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements Medical Device
Notice of the State Administration of Food and Drug Administration on Issuing the Sub Catalogue of in vitro Diagnostic Reagent Classification
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械管[2013]242号 Pre-Market 2013-11-26 2013-11-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the State Administration for Food and Drug Administration on Relevant Issues Concerning the Supervision of Small Medical Oxygen Absorbers
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办法[2013]63号 Pre-Market 2013-09-23 2013-09-16
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Non-Medical Device
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