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Latest Regulations

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Announcement of the State Food and Drug Administration on approving the release of 120 recommended medical device industry standards, including YY/T 0090-2014 Uterine Scraper
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2014年第30号 Product Type Testing 2014-06-17 2015-07-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Implantable Heart Electrode Wire Products
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第10号 Registration & Filing 2014-06-04 2014-06-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement of the State Food and Drug Administration on Matters Related to the Filing of Medical Device Production and Operation
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2014年第25号 Manufacturing,Distribution 2014-05-30 2014-05-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements 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
Announcement of the State Food and Drug Administration on Matters Related to the Filing of Class I Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2014年第26号 Registration & Filing 2014-05-30 2014-05-30
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements IVD
Notice of the General Office of the Food and Drug Administration on Further Improving the Disclosure of Medical Device Recall Information
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监[2014]107号 Supervision & Inspection,Distribution 2014-05-29 2014-05-29
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 Guiding Principles for Technical Review of 14 Medical Device Products Registration, including Medical Masks
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第7号-f10 Registration & Filing 2014-05-20 2014-05-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of 14 Medical Device Products, including Disposable Drainage Tubes
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第7号-f11 Registration & Filing 2014-05-20 2014-05-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Cardiac Radiofrequency Ablation Catheters
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第5号 Registration & Filing 2014-05-14 2014-05-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Five Medical Device Products, including Metal Plate Internal Fixation Systems
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第6号-f5 Registration & Filing 2014-05-14 2014-05-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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