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Latest Regulations

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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
Medical Device Sampling and Adverse Event Monitoring Part (1)
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150122-3 Supervision & Inspection,Usage 2015-01-22 2015-01-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Part 1 of the Measures for the Supervision and Administration of Medical Device Operation
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150122-2 Distribution 2015-01-22 2015-01-22
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
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
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 Supervision & Inspection,Manufacturing 2014-12-29 2015-03-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Soliciting Opinions on the Writing Standards for Common Orthopedic Trauma Product Instructions and the Reference Format for Trauma Product Instructions
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20141223-1 Pre-Market 2014-12-23 2014-12-23
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
Guidelines for clinical trials of large artery covered stent systems (draft for comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20141219 Clinical Evaluation 2014-12-19 2014-12-19
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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
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