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Latest Regulations

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Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Intervertebral Fusion Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第70号-f6 Registration & Filing 2016-04-26 2016-04-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Dental Base Polymer Materials
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第70号-f2 Registration & Filing 2016-04-26 2016-04-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing a Risk List and Inspection Points for the Production Process of 25 Medical Devices, including Disposable Sterile Syringes
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2016]37号 Supervision & Inspection,Manufacturing 2016-04-13 2016-04-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Technical guidelines for clinical evaluation of pulse oximeter equipment
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20160405 Clinical Evaluation 2016-04-05 2016-04-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice of the State Administration on the Implementation of the Naming Rules for Common Names of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械管[2016]35号 Pre-Market 2016-03-30 2016-03-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Announcement of the State Administration on the Approval and Release of 93 Medical Device Industry Standards, including YY 0053-2016 "Hemodialysis and Related Treatment Hemodialyzers, Hemodialysis Filters, Hemofilters, and Blood Concentrators"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2016年第74号 Product Type Testing 2016-03-23 2017-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice of the State Administration on Issuing Six Documents, including the Model Application and Approval Form for Ethical Review of Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第58号 Clinical Evaluation 2016-03-23 2016-03-15
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements Medical Device
Interpretation of the Quality Management Standards for Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20160323 Clinical Evaluation 2016-03-23 2016-03-23
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents Medical Device
Quality Management Specification for Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局&国家卫计委令2016年第25号 Clinical Evaluation 2016-03-23 2016-06-01
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Notice on Relevant Issues in the Evaluation of Contact Lens Products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20160316 Product Type Testing 2016-03-16 2016-03-16
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device
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