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Latest Regulations

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Announcement of the State Administration of Industry and Commerce on the Release of Cold Chain (Transportation, Storage) Management Guidelines for Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2016年第154号 Usage,Distribution,Manufacturing 2016-09-22 2016-09-19
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the State Administration on Issuing Guidelines for Writing Annual Self inspection Reports on Quality Management Systems of Medical Device Manufacturing Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第76号 Manufacturing 2016-04-28 2016-04-28
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements IVD
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
Notice of the State Administration on the Implementation of Quality Management Standards for Medical Device Production by Class III Medical Device Production Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第19号 Supervision & Inspection,Manufacturing 2016-02-05 2016-02-05
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the General Office of the State Council on Effectively Implementing Quality Management Standards for Medical Device Production in Third Class Medical Device Production Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监[2016]12号 Manufacturing 2016-02-05 2016-02-05
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 Guidelines for Quality Management of Process Water for Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第14号 Manufacturing 2016-01-29 2016-01-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Food and Drug Administration on Matters Related to Product Registration and Production License for Domestic Medical Device Production Enterprises Opening New Enterprises Across Provinces
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第203号 Manufacturing 2015-10-21 2015-10-21
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the State Food and Drug Administration on Matters Related to the Production of Disposable Sterile Injection and Infusion Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第71号 Manufacturing 2015-10-12 2015-10-12
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice of the State Administration for Food and Drug Administration on Issuing Four Guiding Principles, including the Guidelines for On site Inspection of Medical Device Production Quality Management Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2015]218号-f1 Manufacturing 2015-09-25 2015-09-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration for Food and Drug Administration on Issuing Four Guiding Principles, including the Guidelines for In Vitro Diagnostic Reagent Field Inspection in Medical Device Production Quality Management Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2015]218号-f4 Supervision & Inspection,Manufacturing 2015-09-25 2015-09-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
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