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Latest Regulations

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Notice of the State Administration for Food and Drug Administration on Issuing Four Guiding Principles, including the Quality Management Standards for Medical Device Production and the Guiding Principles for Aseptic Medical Device Site Inspection
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2015]218号-f2 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 On site Inspection of Implantable Medical Devices in accordance with the Quality Management Standards for Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2015]218号-f3 Manufacturing 2015-09-25 2015-09-25
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 Issuing the Appendix of Good Manufacturing Practice for Medical Devices - In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第103号 Manufacturing 2015-07-10 2015-07-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Food and Drug Administration on Issuing the Appendix of Quality Management Standards for Medical Device Production for Implantable Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第102号 Manufacturing 2015-07-10 2015-10-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement of the State Food and Drug Administration on Issuing the Appendix to the Quality Management Standards for Medical Device Production for Sterile Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第101号 Manufacturing 2015-07-10 2015-07-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Part 1 of the Measures for the Supervision and Administration of Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150122-1 Manufacturing 2015-01-22 2015-01-22
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents Medical Device
Part 1 of the Measures for the Supervision and Administration of Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150122-1 Manufacturing 2015-01-22 2015-01-22
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents Medical Device
Part 1 of the Measures for the Supervision and Administration of Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150122-1 Manufacturing 2015-01-22 2015-01-22
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents Medical Device
Notice of the State Food and Drug Administration on Issuing Guidelines for Supplier Audit of Medical Device Manufacturing Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第1号 Manufacturing 2015-01-19 2015-01-19
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Food and Drug Administration on Issuing Quality Management Standards for Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2014年第64号 Supervision & Inspection,Manufacturing 2014-12-29 2015-03-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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