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Latest Regulations

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Letter on Soliciting Opinions on the Management Measures for Medical Device Supervision Inspectors
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监便函[2014]129号 Supervision & Inspection 2014-12-30 2014-12-30
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Normative Documents IVD
Letter on Soliciting Opinions on the Management Measures for Medical Device Supervision Inspectors
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监便函[2014]129号 Supervision & Inspection 2014-12-30 2014-12-30
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Normative Documents 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 Manufacturing,Supervision & Inspection 2014-12-29 2015-03-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the General Office of the Food and Drug Administration on Standardizing and Unifying the Special Seal for Advertising Review in Various Regions
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办稽[2014]206号 Supervision & Inspection,Distribution 2014-12-17 2015-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Announcement of the State Food and Drug Administration on the Implementation of Quality Management Standards for Medical Device Operation
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2014年第58号 Supervision & Inspection,Distribution 2014-12-12 2014-12-12
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the State Food and Drug Administration on the Implementation of Quality Management Standards for Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第15号 Manufacturing,Supervision & Inspection 2014-09-05 2014-09-05
Status Issued By Level of Legal Effect Product Category Valid 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 General Office of the Food and Drug Administration on Issuing Guidelines for Daily Supervision and On site Inspection of Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监[2014]7号 Manufacturing,Supervision & Inspection 2014-01-13 2014-01-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Explanation on the Administrative Reconsideration Measures of the State Food and Drug Administration
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20131206 Supervision & Inspection 2013-12-06 2013-12-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Administrative Reconsideration Measures of the State Food and Drug Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2013年第2号 Supervision & Inspection 2013-11-06 2014-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
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